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Medical Devices Law and Regulation Answer Book 2013
 by Suzan Onel, Karen M. Becker, Ph.D.
 
 Copyright: 2012

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  • ISBN Number: 9781402418372
  • Page Count: 1014
  • Number of Volumes: 1
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The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976.  Medical Devices Law and Regulation Answer Book 2013 walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation.

With over 30 contributors from a variety of major law firms and consulting firms specializing in medical device work, Medical Devices Law and Regulation Answer Book 2013 provides practical guidance on how to handle every day questions on a wide variety of topics as well as what issues are likely to arise and how to avoid them.  The breadth of coverage of this new publication is illustrated by the chapter titles provided below:

Overview of Medical Device Regulation in the U.S. • Clinical Studies of Investigational Devices • Device Premarket Submissions • Devices with Unique Issues – Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software • In Vitro Diagnostic (IVD) Devices • The Quality System Regulation • Device Facility Inspections • Post Market Considerations • International Considerations • Enforcement and Government Investigations Regarding Medical Devices • Interacting with FDA • Intellectual Property Considerations for Medical Device Companies • Fraudulent and Abusive Practices in the Reimbursement for Medical Devices • HIPAA’s Impact on the Medical Device Manufacturing Community • Continuing Medical Education (CME) and Industry-Supported Scientific Activities • Litigation, Product Liability, and Preemption • Licensing, Product Development and Commercialization • FDA Criminal Enforcement • Overlapping Jurisdiction with other Agencies and Law Enforcement Entities • Commonly Used Acronyms

  Foreword; Introduction; And Table of Abbreviations
Chapter 1: Overview of the Legal Framework for Medical Device Regulation in the United States Ellen J Flannery, JD ~ Covington & Burling LLP
  • Q 1.1 : What law regulates medical devices?2
  • Q 1.2 : How did medical device regulation develop?3
  • Q 1.3 : What kinds of regulatory requirements apply to medical devices?4
  • Q 1.4 : What is a medical device?4
  • Q 1.5 : How do I know whether my product is regulated as a “medical device”?5
  • Q 1.6 : How are devices regulated under the statutory framework?6
  • Q 1.7 : What are the premarket requirements for medical devices?6
  • Q 1.8 : What are the key differences between the 510(k) premarket notification and the premarket approval procedures?7
  • Q 1.9 : How does FDA know what devices are being marketed in the United States?7
  • Q 1.10 : What are the establishment registration requirements?8
  • Q 1.11 : What are the device listing requirements?8
  • Q 1.12 : Who is required to register and list?8
  • Q 1.13 : What device listing requirements apply to importers of a device?9
  • Q 1.14 : What information is required under the device listing regulations?9
  • Q 1.15 : Do the device establishment registration and device listing requirements apply to foreign manufacturers?10
  • Q 1.16 : How can a manufacturer ensure that a medical device meets regulatory requirements to be marketed in the United States?10
  • Q 1.17 : What is a 510(k) notification?10
    • Q 1.17.1 : What does “substantially equivalent” mean?11
    • Q 1.17.2 : What information must be included in a 510(k) notification?11
    • Q 1.17.3 : How long does it take to receive marketing clearance of a device under the 510(k) notification pathway?12
    • Q 1.17.4 : Can review of a 510(k) notification be expedited?12
    • Q 1.17.5 : What happens if FDA determines that the device is “not substantially equivalent”?12
    • Q 1.17.6 : What happens after FDA determines a device to be “substantially equivalent”?13
    • Q 1.17.7 : How does FDA determine the “intended use” of a device?13
    • Q 1.17.8 : Why are some Class III devices marketed under a 510(k) notification?13
    • Q 1.17.9 : Can a manufacturer make changes to its device after receiving 510(k) clearance?14
    • Q 1.17.10 : Are there other types of 510(k) notifications?14
  • Q 1.18 : When is a PMA required?15
    • Q 1.18.1 : What if a manufacturer is uncertain whether a 510(k) or a PMA is required for its device?15
    • Q 1.18.2 : What information is required in a PMA?15
    • Q 1.18.3 : What if the PMA does not include all the required information?16
    • Q 1.18.4 : What is a “modular PMA”?17
    • Q 1.18.5 : How long does it take to get approval of a PMA?17
    • Q 1.18.6 : How does the PMA review proceed?17
    • Q 1.18.7 : Can review of a PMA be expedited?18
    • Q 1.18.8 : Can another company show that its device is substantially equivalent to a PMA device and receive a 510(k) notification?18
    • Q 1.18.9 : What if a manufacturer wants to modify a PMA device?18
  • Q 1.19 : What requirements apply to clinical studies of a device in human subjects?19
  • Q 1.20 : What do the IDE regulations require?20
  • Q 1.21 : Can a sponsor modify an investigational device, or change the study protocol, in the middle of an IDE clinical study?20
  • Q 1.22 : How does a sponsor find out from FDA what clinical data are required for a PMA or 510(k) notification?21
  • Q 1.23 : Can a sponsor charge for an investigational device?21
  • Q 1.24 : What options are available to device manufacturers who want to develop a device for a disease or condition affecting a small number of people?22
  • Q 1.25 : What are the requirements for obtaining a humanitarian device exemption?22
  • Q 1.26 : What requirements apply to use of a humanitarian device?23
  • Q 1.27 : Can a sponsor charge for a humanitarian use device?23
  • Q 1.28 : Are there other limitations on the humanitarian device exemption?24
  • Q 1.29 : Are device manufacturers required to submit reports to FDA after obtaining marketing clearance or approval of a medical device?24
  • Q 1.30 : What MDR requirements apply to a device manufacturer?24
  • Q 1.31 : When must a manufacturer’s MDR report be submitted?25
  • Q 1.32 : What MDR requirements apply to importers of a device?25
  • Q 1.33 : What MDR requirements apply to a device user facility?25
  • Q 1.34 : What MDR requirements apply to distributors of a device?26
  • Q 1.35 : Are other kinds of reports required to be submitted to FDA?26
  • Q 1.36 : When is a notice of correction and removal required?26
  • Q 1.37 : Does FDA monitor postmarket experience with devices in other ways?26
  • Q 1.38 : What happens if a manufacturer receives a postmarket surveillance order?27
  • Q 1.39 : How long must postmarket surveillance be conducted?27
  • Q 1.40 : Does FDA have any special recordkeeping or reporting requirements for high-risk devices?27
  • Q 1.41 : What kinds of devices might be subject to device tracking requirements?28
  • Q 1.42 : What is the purpose of the device tracking requirements?28
  • Q 1.43 : Are manufacturers required to have a method of tracking every device they market?28
  • Q 1.44 : Does FDA have authority to restrict the distribution of medical devices?29
  • Q 1.45 : What kinds of restrictions can FDA impose?29
  • Q 1.46 : Does FDA regulate the manufacturing of medical devices?29
  • Q 1.47 : How does FDA enforce the QSR requirements?30
  • Q 1.48 : Are manufacturers required to conform to standards in designing or manufacturing a medical device?30
  • Q 1.49 : What is a “Declaration of Conformity”?31
  • Q 1.50 : What happens if a device fails to conform to an applicable standard?31
  • Q 1.51 : What can a manufacturer do if it does not agree with a decision that has been made by an FDA employee during IDE, 510(k), or PMA review?31
  • Q 1.52 : What can a manufacturer do if there is a scientific dispute with FDA that does not seem to be resolvable within the agency?32
  • Q 1.53 : What if a device does not comply with a requirement of the FDCA?32
  • Q 1.54 : What are the enforcement actions that can result from a prohibited act?32
  • Q 1.55 : Can FDA require a product recall?33
  • Q 1.56 : Can FDA withdraw marketing authorization for a device?33
  • Q 1.57 : Do other agencies or entities regulate medical devices?34
Chapter 2: Clinical Studies of Investigational Devices Jack A Kent ~ Becker & Associates Consulting Inc
Seth A. Mailhot, JD ~ Sheppard Mullin Richter & Hampton LLP
  • Q 2.1 : What information is necessary to establish the safety and effectiveness of a medical device, or the substantial equivalence of a medical device to a predicate device?43
  • Q 2.2 : What are the differences between bench testing, nonclinical laboratory studies and clinical trials?43
  • Q 2.3 : What requirements apply to bench testing?44
  • Q 2.4 : Do I need permission from the U.S. Food and Drug Administration before beginning a nonclinical laboratory study of a medical device?44
  • Q 2.5 : What requirements apply to the conduct of nonclinical laboratory studies?45
  • Q 2.6 : If the sponsor conducts a nonclinical laboratory study in-house, is the sponsor required to comply with the GLP Regulation?45
  • Q 2.7 : What is a sponsor required to do if it contracts for the conduct of any portion of a nonclinical laboratory study with a consulting laboratory or contractor, whether through a grant or otherwise?46
  • Q 2.8 : How long must a sponsor of a nonclinical laboratory study maintain records of the study?46
  • Q 2.9 : What types of medical device studies are regulated by the U.S. Food and Drug Administration?47
  • Q 2.10 : Do I need permission from the U.S. Food and Drug Administration or other regulatory authority before beginning a clinical study of a medical device?47
    • Q 2.10.1 : Are there any exemptions from FDA approval?48
  • Q 2.11 : How does one determine whether a device is significant risk (SR) or nonsignificant risk (NSR)?48
  • Q 2.12 : What is an IDE?49
  • Q 2.13 : What is required to obtain FDA approval for a clinical study?49
  • Q 2.14 : What is the timing of the review of an IDE and what is FDA’s standard for the review of an IDE?50
  • Q 2.15 : What is the sponsor’s obligation to monitor a study?52
  • Q 2.16 : What is required of a sponsor in monitoring investigators involved in a study?52
  • Q 2.17 : What is required to make a change to an IDE after it has been approved?53
  • Q 2.18 : May an investigational device be used to treat patients outside of a clinical trial prior to the clearance or approval of the device?53
  • Q 2.19 : May a sponsor charge institutions, investigators or subjects/patients for the use of an investigational device?54
  • Q 2.20 : What confidentiality applies to an IDE application and a clinical study?54
  • Q 2.21 : How long must a sponsor keep records of a clinical study?55
  • Q 2.22 : Do any user fees apply to an IDE application?55
  • Q 2.23 : What are the reporting requirements to FDA? To the IRB? To investigators?55
  • Q 2.24 : What must be disclosed to patients or subjects participating in a clinical trial?58
  • Q 2.25 : Is documented informed consent required for every patient or subject participating in a clinical trial?59
    • Q 2.25.1 : Are there exceptions to the requirement of documented informed consent?60
  • Q 2.26 : May the documentation of informed consent also serve as a waiver for liability?61
  • Q 2.27 : If a foreign clinical trial will be used to obtain clearance or approval of a medical device, must the foreign clinical trial be conducted under an IDE?62
  • Q 2.28 : What is required for FDA to accept a foreign clinical trial of a medical device as evidence of its safety and/or efficacy?62
  • Q 2.29 : Can a foreign medical device company sponsor a U.S. clinical trial?62
  • Q 2.30 : What must sponsors of a clinical study disclose to FDA about the financial interests of a clinical investigator?63
  • Q 2.31 : What records are investigators required to maintain during and after a clinical study?63
  • Q 2.32 : What are the reporting requirements for investigators?64
  • Q 2.33 : What is ClinicalTrials.gov?64
  • Q 2.34 : What device clinical studies must be registered on ClinicalTrials.gov?65
  • Q 2.35 : Must foreign clinical trials be registered on ClinicalTrials.gov?65
  • Q 2.36 : Who is responsible for registering the clinical trials on ClinicalTrials.gov?66
  • Q 2.37 : What information about a clinical study must be provided on ClinicalTrials.gov?66
  • Q 2.38 : Is it permissible to promote a clinical study to encourage enrollment?67
  • Q 2.39 : Is it permissible to discuss the results of clinical studies before the investigational device is cleared or approved?67
  • Q 2.40 : Is it possible to discuss the design of a clinical trial protocol with FDA before submitting an IDE?68
  • Q 2.41 : What is involved with an informal early collaboration meeting?69
  • Q 2.42 : What is involved with a formal early collaboration meeting?69
  • Q 2.43 : What other opportunities are there for early collaboration with FDA?70
Chapter 3: Device Premarket Submissions Jeffrey K Shapiro, JD ~ Hyman Phelps & McNamara
  • Q 3.1 : What are the different device classifications and what kinds of premarket submissions are available?76
  • Q 3.2 : What are the potential device classifications?76
  • Q 3.3 : Are all devices covered by the current classification regulations?77
  • Q 3.4 : If a device has not been classified, how can I request FDA information regarding the classification of a device?78
  • Q 3.5 : What are the consequences of the classification determination?78
  • Q 3.6 : What is device reclassification?78
  • Q 3.7 : What is the procedure for device reclassification?79
  • Q 3.8 : What medical devices are exempt from premarket review?79
  • Q 3.9 : What could cause a device to lose its exempt status?79
  • Q 3.10 : What are the pathways to market for medical devices?80
  • Q 3.11 : What is 510(k) clearance?80
  • Q 3.12 : What is the difference between 510(k) approval and 510(k) clearance?81
  • Q 3.13 : What is the basis for finding “substantial equivalence”?81
  • Q 3.14 : How many predicate devices are needed?84
  • Q 3.15 : What is the procedure for obtaining 510(k) clearance?84
  • Q 3.16 : What are the essential elements of a 510(k) submission?84
  • Q 3.17 : Does FDA offer presubmission assistance with 510(k) submissions?86
    • Q 3.17.1 : How can FDA be contacted for presubmission assistance?86
    • Q 3.17.2 : What is FDA’s pre-IDE program?87
  • Q 3.18 : Once a submission is under FDA review, what interaction with FDA is likely?88
  • Q 3.19 : What may “stop” the review clock?88
  • Q 3.20 : How long does it typically take to obtain clearance?89
  • Q 3.21 : What are the next steps if your submission is found not substantially equivalent (NSE)?89
  • Q 3.22 : What user fees are charged?90
  • Q 3.23 : What is the third-party review program?90
  • Q 3.24 : When might it be a good idea to use the third-party review program?90
  • Q 3.25 : When is a new 510(k) clearance required for device modifications?91
  • Q 3.26 : Can a cleared 510(k) be supplemented?91
  • Q 3.27 : What is a Special 510(k)?92
  • Q 3.28 : What is an Abbreviated 510(k)?92
  • Q 3.29 : Can FDA rescind a 510(k) clearance?92
  • Q 3.30 : What is de novo classification?93
  • Q 3.31 : What is the procedure for obtaining de novo classification?93
  • Q 3.32 : What is the legal effect of de novo classification?94
  • Q 3.33 : What are the requirements for PMA approval?94
  • Q 3.34 : What is the procedure for obtaining PMA approval?95
  • Q 3.35 : What is the regulatory standard for PMA approval?96
  • Q 3.36 : What are the essential elements of a PMA application?96
  • Q 3.37 : What are modular PMAs?97
  • Q 3.38 : Does FDA offer presubmission assistance with PMA applications?97
  • Q 3.39 : Once a PMA is under FDA review, what are the key milestones?97
  • Q 3.40 : Once a PMA is under FDA review, what interaction with FDA is likely?98
  • Q 3.41 : What may “stop” the review clock?99
  • Q 3.42 : What is the likelihood of an advisory panel review?99
  • Q 3.43 : How do I prepare for an advisory panel meeting?99
  • Q 3.44 : What is a PMA Amendment?100
  • Q 3.45 : How long does it typically take to obtain approval?100
  • Q 3.46 : What are the next steps if my PMA is not approved?100
  • Q 3.47 : When are PMA supplements required?101
  • Q 3.48 : What user fees are charged?102
  • Q 3.49 : Can FDA withdraw a PMA approval?102
  • Q 3.50 : What is HUD/HDE approval?102
  • Q 3.51 : What is the procedure for obtaining HUD/HDE approval?103
  • Q 3.52 : What are the essential elements of an HDE application?104
  • Q 3.53 : When are HDE supplements required?105
  • Q 3.54 : What user fees are charged?105
  • Q 3.55 : What is the legal standard for approval?105
  • Q 3.56 : Are these similar to orphan drugs?105
  • Q 3.57 : What is a pediatric medical device?106
  • Q 3.58 : Is there a special pathway to market?106
  • Q 3.59 : What special considerations are involved in getting to market?107
  • Q 3.60 : What is a PDP?107
  • Q 3.61 : How practical is it to seek a PDP?107
  • Q 3.62 : What information may FDA release about a pending submission?108
  • Q 3.63 : What information may FDA release about a submission denied clearance or approval, or that has been withdrawn?109
  • Q 3.64 : What information may FDA release about a submission after clearance or approval?109
  • Q 3.65 : Can a company prevent disclosure by labeling information as confidential?110
  • Q 3.66 : How can a company request information on a competitor’s product submission?110
Chapter 4: Devices with Unique Issues--Combination Devices, Radiological Devices, Restricted Devices, Custom Devices, and Device Software
  • Q 4.1 : What are combination devices?118
  • Q 4.2 : Which FDA Center will lead the premarket review?119
    • Q 4.2.1 : What is “primary jurisdiction” and “primary mode of action” (PMOA)?119
    • Q 4.2.2 : Are there any publicly available documents to help a company anticipate the most likely lead Center?119
    • Q 4.2.3 : What is the role of the Office of Combination Products (OCP)?120
    • Q 4.2.4 : When should a company submit a formal “request for designation” (RFD)?120
    • Q 4.2.5 : What information needs to be provided in a RFD?121
    • Q 4.2.6 : Can a company appeal a product designation issued by OCP?122
  • Q 4.3 : Can a company rely on constituent product data and information to establish safety and effectiveness?122
  • Q 4.4 : Will two premarket applications need to be submitted?122
    • Q 4.4.1 : Is the lead Center solely responsible for reviewing the premarket applications?123
    • Q 4.4.2 : How are user fees assessed?124
  • Q 4.5 : Which quality control regulations apply?124
  • Q 4.6 : How should companies report adverse events?125
    • Q 4.6.1 : Who is subject to the proposed rule?126
  • Q 4.7 : How should post-approval modifications or changes to constituent parts be assessed?126
  • Q 4.8 : What electronic products are regulated by FDA?127
  • Q 4.9 : How are radiation-emitting electronic products regulated?127
  • Q 4.10 : Are there any exemptions from performance standards?128
  • Q 4.11 : When can a manufacturer begin marketing an electronic product that emits radiation?128
  • Q 4.12 : Can a manufacturer begin importing a radiation-emitting electronic product before receipt of an acknowledgment letter?129
  • Q 4.13 : What is a certification?129
  • Q 4.14 : What requirements are applicable to components of electronic products?130
  • Q 4.15 : What specific requirements apply to imports?130
  • Q 4.16 : What enforcement powers does CDRH have over non-compliant electronic products that emit radiation?130
  • Q 4.17 : Are radiation-emitting medical devices regulated differently?131
  • Q 4.18 : What is the MQSA?131
  • Q 4.19 : What are restricted devices?132
  • Q 4.20 : What are typical restrictions?133
  • Q 4.21 : Are restricted devices the same as “prescription devices”?133
  • Q 4.22 : What are some examples of devices restricted by regulation?133
  • Q 4.23 : Does FDA require prior approval of advertising for restricted devices?134
  • Q 4.24 : What are custom devices?134
  • Q 4.25 : What are the legal/regulatory benefits to being considered a “custom” device?135
  • Q 4.26 : Are all devices that are created for specific patients custom devices?135
  • Q 4.27 : What are the legal/regulatory risks of selling a device as a custom device?135
  • Q 4.28 : Is software regulated by FDA?136
  • Q 4.29 : What is stand-alone software?137
  • Q 4.30 : How is stand-alone software regulated?137
    • Q 4.30.1 : What is exemption by statutory interpretation?137
    • Q 4.30.2 : What is exemption by FDA regulation?138
    • Q 4.30.3 : What is exemption due to competent human intervention?138
  • Q 4.31 : How is software regulated when it is integrated with a medical device or intended to be used with a medical device?139
    • Q 4.31.1 : How is software as a component or part treated?139
    • Q 4.31.2 : How is software as an accessory treated?139
  • Q 4.32 : Are there unique issues that need to be addressed in premarket submissions?140
  • Q 4.33 : Do manufacturers using off-the-shelf (OTS) software with their medical devices need to obtain clearance to use the OTS software?141
  • Q 4.34 : What if device software is changed after a product is marketed?142
  • Q 4.35 : Are electronic patient record systems regulated as medical devices?143
    • Q 4.35.1 : What are some examples of electronic health information systems actively regulated by FDA?144
  • Q 4.36 : How are mobile health devices and related applications (“apps”) regulated?146
Chapter 5: In Vitro Diagnostic (IVD) Devices M. Jason Brooke, JD ~ Epstein Becker & Green PC
Bradley Merrill Thompson, JD ~ Epstein Becker & Green PC
  • Q 5.1 : What is an in vitro diagnostic product?154
  • Q 5.2 : How is an IVD regulated?155
  • Q 5.3 : How are IVDs classified within the medical device classification scheme?155
  • Q 5.4 : How does FDA look at Quality Control for IVDs?157
  • Q 5.5 : Who at FDA regulates IVDs?158
  • Q 5.6 : Who else regulates IVDs at FDA?159
  • Q 5.7 : How is research conducted on IVDs?159
  • Q 5.8 : How are clinical investigations conducted on IVDs?160
  • Q 5.9 : What is an Investigational Device Exemption (IDE)?160
  • Q 5.10 : What is the “pre-IDE” process for IVDs?160
  • Q 5.11 : Is FDA willing to review and discuss a study protocol even if the study is exempt from most IDE requirements?160
  • Q 5.12 : Can I obtain a more formal evaluation of my study design or investigational plan?161
  • Q 5.13 : When are IVD studies exempt from the IDE requirements?161
  • Q 5.14 : What requirements apply to IDE exempt studies of IVDs?162
  • Q 5.15 : How do I determine if the study is a significant or non-significant risk study?162
  • Q 5.16 : How do I determine if an invasive sampling technique presents a significant risk?163
  • Q 5.17 : What does noninvasive mean for IVD devices or procedures?163
  • Q 5.18 : What does it mean to have “confirmation of the diagnosis by another, medically established diagnostic product or procedure”?164
  • Q 5.19 : What if no medically established means for diagnosing the disease or condition exists?164
  • Q 5.20 : Is it appropriate to use a quality systems approach in the conduct of IVD studies?164
  • Q 5.21 : If a sponsor’s own “in-house” laboratory (e.g., Research and Development department) participates as a study site in an IVD study, should it conduct the study as an external or independent study site?165
  • Q 5.22 : When does an IVD study involve human subjects?165
  • Q 5.23 : When does the “Good Laboratory Practice for Nonclinical Studies” apply to an IVD study?165
  • Q 5.24 : What regulations apply regarding human subject protection in investigational IVD studies?166
  • Q 5.25 : Can investigational IVD studies receive expedited review by an IRB?167
  • Q 5.26 : Can leftover specimens be used in IVD studies without informed consent?167
  • Q 5.27 : Can those who routinely do studies with IVDs (e.g., research hospitals) use a general informed consent to address future studies using samples collected in their own facility?167
  • Q 5.28 : Can a human specimen that was initially collected in an IVD study with the informed consent of the subject be used in a later IVD study without a new consent process?168
  • Q 5.29 : Can an investigational IVD device be used outside of the study protocol in an emergency situation?168
  • Q 5.30 : Can an unapproved or uncleared investigational IVD device ever be used for non-emergency treatment of patients who do not meet the inclusion criteria of an investigational study?169
  • Q 5.31 : Are treatment IDEs and continued access available for investigational IVDs under an IDE?170
  • Q 5.32 : Can an IVD device be considered a humanitarian use device (HUD) and does the humanitarian device exemption (HDE) apply for marketing approval?170
  • Q 5.33 : Can an IVD device qualify for HUD designation if the affected patient population is fewer than 4,000 per year but each patient may need to be tested multiple times?170
  • Q 5.34 : When is an IVD exempt from the premarket notification requirement?171
  • Q 5.35 : What review criteria does FDA use for an IVD 510(k) submission?171
  • Q 5.36 : What questions does FDA ask in the review of an IVD 510(k)?172
  • Q 5.37 : What types of studies does FDA require to demonstrate substantial equivalence for an IVD?172
  • Q 5.38 : What other information must be in an IVD premarket notification?173
    • Q 5.38.1 : Specifically, what name should be included?174
    • Q 5.38.2 : What information and data supportive of a substantial equivalency claim should be included?175
    • Q 5.38.3 : Is an “indications for use” statement required?175
    • Q 5.38.4 : Should the 510(k) state conformance to voluntary standards and standards identified in guidance documents?175
  • Q 5.39 : Is there a way to seek expedited review of a 510(k) submission?176
  • Q 5.40 : What benefit-risk criteria does FDA use for an IVD premarket approval or de novo submission?176
  • Q 5.41 : Are IVDs intended for home use reviewed differently?178
  • Q 5.42 : What key factors does CDRH consider?179
  • Q 5.43 : What studies need to be conducted to support a home-use 510(k)?180
  • Q 5.44 : What studies are required to demonstrate safety and effectiveness?182
  • Q 5.45 : What is de novo classification for IVDs?182
  • Q 5.46 : Where can we find the specific rules for conducting IVD clinical studies?183
  • Q 5.47 : Can published literature be used to support an IVD premarket submission?183
  • Q 5.48 : Can data from studies performed outside the United States be used to support an IVD premarket submission?183
    • Q 5.48.1 : Can foreign/international data be used as the sole support of a marketing application?184
  • Q 5.49 : What information should the protocol include to ensure that the investigational IVD study will be scientifically sound?184
  • Q 5.50 : What guidance is available for sponsors to determine how to estimate IVD performance in terms of sensitivity and specificity, how to handle discrepant results, and what to do when a study is performed without a truth standard?184
  • Q 5.51 : How much leeway is there in deciding on the populations from which human specimens are collected and under what conditions are data on simulated specimens acceptable?185
  • Q 5.52 : Is it acceptable to eliminate data that appear to be out of line with the main body of the dataset (i.e., “outliers”)?185
  • Q 5.53 : Is it acceptable to add additional readings on the same subject to the dataset, particularly when it is hard to find study subjects?185
  • Q 5.54 : How much precision is needed for measurement data (e.g., in terms of decimal places)?186
  • Q 5.55 : What records should help to ensure scientific soundness of an IVD investigational study?186
  • Q 5.56 : What does FDA recommend to include in the final report of the investigation from the sponsor to all reviewing IRBs (and to FDA for significant risk studies)?187
  • Q 5.57 : What are the requirements for IVD labeling?187
  • Q 5.58 : What are the label requirements for the immediate container?187
  • Q 5.59 : What are the labeling requirements for inserts and outer packaging?189
  • Q 5.60 : Are there exemptions from the labeling requirements?191
  • Q 5.61 : Are there special labeling rules for general purpose reagents and equipment?192
  • Q 5.62 : Are there special rules for labeling IVDs for home use?193
  • Q 5.63 : What are the controversial aspects of the draft guidance?196
  • Q 5.64 : What makes RUO and IUO IVDs unique?196
  • Q 5.65 : Are RUO and IUO IVDs exempt from FDA regulation?197
  • Q 5.66 : Are foreign manufacturers of RUO and IUO IVDs exempt from FDA regulation?197
  • Q 5.67 : What types of products does FDA generally consider to be appropriately labeled “Research Use Only” IVD products?198
  • Q 5.68 : What types of IVD products should not be labeled RUO?198
  • Q 5.69 : What types of products does FDA generally consider to be appropriately labeled “Investigational Use Only” IVD products?199
  • Q 5.70 : What types of IVD products should not be labeled IUO?199
  • Q 5.71 : Are RUO and IUO IVD products required to be manufactured in compliance with the Quality System regulation?200
  • Q 5.72 : How may IVD products labeled RUO or IUO be marketed?200
  • Q 5.73 : What marketing practices would FDA consider to be generally inappropriate for IVD products labeled RUO or IUO?200
  • Q 5.74 : What should a manufacturer do if it learns that one of its clinical laboratory customers wants to use an IVD product labeled RUO or IUO in clinical diagnosis?202
  • Q 5.75 : Can a manufacturer obtain clearance or approval for an IVD product that includes or is required to be used with one or more IUO- and/or RUO-labeled reagents or instruments?202
  • Q 5.76 : Should a manufacturer or distributor promote IVD components, instruments, or reagents labeled RUO or IUO for use in a Laboratory Developed Test (LDT) that the manufacturer knows is used in clinical diagnosis?203
  • Q 5.77 : Should the manufacturer include instructions for use with an IVD product labeled RUO or IUO?203
  • Q 5.78 : Is it appropriate for a manufacturer or distributor to market software labeled RUO or IUO?204
  • Q 5.79 : Should the manufacturer of an IVD product labeled RUO or IUO help with the validation and verification of performance specifications of an LDT or other test that the manufacturer knows is used in clinical diagnosis that utilizes its product?204
  • Q 5.80 : What are Analyte Specific Reagents?205
  • Q 5.81 : What is a General Purpose Reagent?206
  • Q 5.82 : What is a LDT?206
  • Q 5.83 : What is an In Vitro Diagnostic Multivariate Index Assay?206
  • Q 5.84 : Why did FDA create the ASR category?207
  • Q 5.85 : How are ASRs regulated?208
  • Q 5.86 : What labeling restrictions apply to ASRs?209
  • Q 5.87 : What other restrictions apply?209
  • Q 5.88 : How are ASRs classified?210
  • Q 5.89 : If an ASR is in Class I, does that mean it is exempt?211
  • Q 5.90 : How does the classification of ASRs compare to the classification of IVDs used for the same purposes?212
  • Q 5.91 : Are there other limits on the promotion of ASRs?213
  • Q 5.92 : What was the reaction to the FDA’s draft guidance proposing regulation of IVD companion diagnostic devices?215
  • Q 5.93 : What is an IVD companion diagnostic device?215
  • Q 5.94 : What is the review and approval process of an IVD companion diagnostic device?216
  • Q 5.95 : When would FDA approve a therapeutic product without the cleared or approved IVD companion diagnostic device for which it is labeled?216
  • Q 5.96 : What labeling considerations apply to a therapeutic product and its IVD companion diagnostic device?217
  • Q 5.97 : Can an IVD companion diagnostic device be used for investigational use?219
  • Q 5.98 : What are the Clinical Laboratory Improvement Amendments of 1988 (CLIA)?220
  • Q 5.99 : What laboratories does CLIA regulate?220
  • Q 5.100 : Which agency administers CLIA?220
  • Q 5.101 : What criteria are used under CLIA to categorize tests?221
  • Q 5.102 : How else are tests put in the waived category?221
  • Q 5.103 : What is the CLIA waiver process?222
Chapter 6: The Quality System Regulation Edward C. Wilson, Jr, JD ~ Hogan Lovells US LLP
Michael S. Heyl, JD ~ Hogan Lovells US LLP
  • Q 6.1 : Where can I find the Quality System Regulation requirements?231
  • Q 6.2 : What is the scope of the QSR requirements?231
  • Q 6.3 : What entities are subject to the QSR requirements?231
  • Q 6.4 : How does FDA define “finished device manufacturer”?232
  • Q 6.5 : Do the QSR requirements apply to component and subassembly manufacturers?232
  • Q 6.6 : Are the QSR requirements identical to the ISO requirements?234
  • Q 6.7 : Do finished device manufacturers need two separate systems, one for ISO compliance and one for QSR compliance?234
  • Q 6.8 : If a manufacturer is ISO certified, is it also compliant with the QSR requirements?234
  • Q 6.9 : What areas are covered under the QSR?235
  • Q 6.10 : Are finished device manufacturers required to comply with every element of the QSR?235
    • Q 6.10.1 : What if a finished device manufacturer by nature of its business does not conduct every activity that is described in the QSR?235
    • Q 6.10.2 : What should a manufacturer do if it believes that it is not subject to certain provisions of the QSR?236
  • Q 6.11 : Are contract manufacturers subject to the QSR requirements?236
  • Q 6.12 : Are foreign manufacturers subject to the QSR requirements?236
  • Q 6.13 : What are the QSR obligations of an initial importer/distributor?237
  • Q 6.14 : Are any resources available to me to better understand FDA QSR requirements?237
  • Q 6.15 : What is the scope of the management responsibility provisions of the QSR?239
  • Q 6.16 : What are the management responsibilities for Quality Policy?239
    • Q 6.16.1 : What are the management responsibilities for ensuring an adequate organizational structure is in place to assure compliance with the QSR?240
    • Q 6.16.2 : What are the responsibilities of a management representative?241
    • Q 6.16.3 : What are the responsibilities of the company for quality planning and quality procedures?241
    • Q 6.16.4 : What are Management Reviews and what requirements must they meet?242
    • Q 6.16.5 : Does FDA have a right to review the results of Management Reviews?242
    • Q 6.16.6 : Does FDA have a right to review corrective and preventive actions that arise from Management Reviews?243
  • Q 6.17 : Who does FDA hold accountable for noncompliance with the QSR requirements?243
  • Q 6.18 : What are the QSR requirements for Quality Audits?244
  • Q 6.19 : Who should perform Quality Audits?245
  • Q 6.20 : What quality functions should be assessed in a Quality Audit Plan/Schedule?245
  • Q 6.21 : How often should Quality Audits be conducted?245
  • Q 6.22 : What is the appropriate goal of a Quality Audit?246
  • Q 6.23 : How should information from a Quality Audit be used?246
  • Q 6.24 : Does FDA have a right to review Quality Audit reports?246
  • Q 6.25 : Does FDA have a right to review corrective and preventive actions that arise from Quality Audits?247
  • Q 6.26 : Who should be trained?247
  • Q 6.27 : Who should conduct training?248
  • Q 6.28 : How are training needs identified?248
  • Q 6.29 : What procedures should a company utilize to ensure compliance with training requirements?248
  • Q 6.30 : Are there any special training requirements applicable to certain personnel?248
  • Q 6.31 : How and where should training be documented?249
  • Q 6.32 : What are the QSR requirements for design controls?249
  • Q 6.33 : Who is subject to design controls?249
  • Q 6.34 : What procedures should the company develop for design planning?249
  • Q 6.35 : What are the requirements for design inputs?250
  • Q 6.36 : What are the requirements for design outputs?250
  • Q 6.37 : What are the requirements for conducting design verification and validation activities?251
  • Q 6.38 : What is the process required for design review?251
  • Q 6.39 : How should design transfer be addressed?252
  • Q 6.40 : What requirements apply when design changes are transferred to manufacturing?252
  • Q 6.41 : What are the recordkeeping requirements for design and development?252
  • Q 6.42 : How is the company’s risk management plan associated with design activities?253
  • Q 6.43 : What are the QSR requirements for purchasing controls?253
  • Q 6.44 : What entities should finished device manufacturers evaluate under the purchasing control provisions of the QSR?254
  • Q 6.45 : What are the finished device manufacturer’s requirements for identifying and qualifying suppliers?254
  • Q 6.46 : How do finished device manufacturers identify the type and extent of control to exercise over its suppliers?254
  • Q 6.47 : Should suppliers to the finished device manufacturer qualify their suppliers?255
  • Q 6.48 : Are finished device manufacturers required to conduct an on-site audit of all of its suppliers?255
  • Q 6.49 : If a finished device manufacturer conducts on-site audits, is FDA allowed to review the supplier audit reports?256
  • Q 6.50 : What recordkeeping requirements exist for finished device manufacturers with regard to suppliers?256
  • Q 6.51 : How should finished device manufacturers balance purchasing controls and acceptance activities over products and services provided by suppliers?257
  • Q 6.52 : How does FDA define “purchasing data”?257
  • Q 6.53 : What are the QSR requirements for production and process controls?258
  • Q 6.54 : What issues should be addressed in the process control procedures?258
  • Q 6.55 : How should companies address changes in production and processes?259
  • Q 6.56 : How should companies address environmental control procedures?259
  • Q 6.57 : How should companies ensure personnel are adequately protected when engaged in production activities?260
  • Q 6.58 : What procedures should companies adopt to protect product and equipment from contamination?260
  • Q 6.59 : How should companies assure facilities and equipment are adequately designed to allow appropriate and safe production of products?260
  • Q 6.60 : How should companies ensure automated processes are properly designed?261
  • Q 6.61 : What are the requirements applicable to the maintenance and calibration of production, measuring and testing equipment?261
  • Q 6.62 : What are the QSR requirements for process validation?262
  • Q 6.63 : When are process validation activities required?262
    • Q 6.63.1 : What procedures should govern process validation activities?262
    • Q 6.63.2 : How should companies monitor and control process parameters?263
  • Q 6.64 : What are the QSR requirements for receiving, in-process, and finished device acceptance?263
    • Q 6.64.1 : How should requirements for incoming acceptance activities be addressed?263
    • Q 6.64.2 : How should the company ensure activities are controlled and acceptable while in-process?264
    • Q 6.64.3 : What procedures should companies adopt for final acceptance?264
    • Q 6.64.4 : What recordkeeping requirements should be adopted for final acceptance and release activities?264
  • Q 6.65 : What disposition methods can be utilized to address nonconforming materials?265
  • Q 6.66 : What are the QSR requirements for nonconforming products?265
  • Q 6.67 : How should companies identify nonconforming products?265
  • Q 6.68 : How should non-conforming products be segregated and handled?266
  • Q 6.69 : What are the QSR requirements for corrective and preventive action?266
  • Q 6.70 : What is the difference between a “corrective” and “preventive” action?266
  • Q 6.71 : What quality system inputs should be included in the Corrective and Preventive Actions (CAPA) system?267
  • Q 6.72 : What processes should manufacturers adopt for initiating, implementing and verifying the effectiveness of corrective and preventive action?267
  • Q 6.73 : What types of records should companies maintain and how long should these records be maintained?268
  • Q 6.74 : What documents related to the QSR are available to the public?268
  • Q 6.75 : What information should be contained in a Device Master Record?268
  • Q 6.76 : What information should be contained in a Device History Record?269
  • Q 6.77 : How does FDA define “complaint”?270
  • Q 6.78 : What information should be included in complaint handling procedures?270
  • Q 6.79 : What are the inputs to the complaint handling system?271
  • Q 6.80 : How and when should reportability of the complaint under the Medical Device Reporting (MDR) regulations be determined?271
  • Q 6.81 : When should MDR events be reported to FDA?272
  • Q 6.82 : What are the requirements regarding whether a complaint investigation should be performed?273
  • Q 6.83 : How should complaint information tie into other quality system functions?273
  • Q 6.84 : What recordkeeping requirements apply to the complaint handling process?274
  • Q 6.85 : What are the QSR requirements for device servicing?274
  • Q 6.86 : How should servicing information correlate with complaint handling?275
  • Q 6.87 : What are the QSR requirements for statistical techniques?275
  • Q 6.88 : How does an entity that is covered by the QSR demonstrate compliance with the QSR?276
  • Q 6.89 : What is FDA’s authority to conduct inspections of medical device manufacturers?276
  • Q 6.90 : How does FDA determine if an entity that is covered by the QSR is compliant with the regulations?277
  • Q 6.91 : What is the Quality System Inspection Technique?278
  • Q 6.92 : Does QSIT impose additional or different requirements on manufacturers?278
  • Q 6.93 : Are FDA investigators required to use this approach when conducting inspections?278
  • Q 6.94 : What are some common FDA inspectional observations?279
  • Q 6.95 : What are the penalties for not complying with the QSR requirements?279
  • Q 6.96 : What can a company do to stay abreast of FDA policies that identify the agency’s current positions with respect to the QSR?280
Chapter 7: Device Facility Inspections Elaine C Messa ~ Becker & Associates Consulting Group, Inc
  • Q 7.1 : What is an inspection and where is it defined?286
  • Q 7.2 : How are types of inspections defined?287
  • Q 7.3 : How are the scope and depth of inspection determined?287
  • Q 7.4 : Where can I find FDA’s authority to conduct inspections?288
  • Q 7.5 : How frequently do inspections occur and why?288
  • Q 7.6 : Are FDA inspections announced?289
  • Q 7.7 : What are FDA’s responsibilities for conducting an inspection?289
  • Q 7.8 : What are the credentials and Notice of Inspection?293
  • Q 7.9 : What areas of a facility may the FDA Investigator enter and inspect?297
  • Q 7.10 : Does FDA have the authority to review and collect records?297
  • Q 7.11 : Will FDA take original records?298
  • Q 7.12 : Are there records or data that the FDA Investigator is not authorized to review?299
  • Q 7.13 : What should I do if FDA asks for a sample?299
  • Q 7.14 : If the appropriate management is not on site for the inspection, should I ask FDA to return at a different time?302
  • Q 7.15 : Should I allow the FDA Investigator to take photographs?304
  • Q 7.16 : Am I required to sign forms or affidavits presented by the FDA Investigator?305
  • Q 7.17 : Does FDA use search warrants when conducting inspections?307
  • Q 7.18 : Are inspection warrants the same as search warrants?308
  • Q 7.19 : What are the scope and depth of FDA medical device inspections?309
  • Q 7.20 : What is the “Systems Approach” to inspections, or QSIT?311
  • Q 7.21 : How do you know when an inspection has ended?313
  • Q 7.22 : What is Form FDA 483, List of Observations?314
  • Q 7.23 : Are Form FDA 483 observations violations of the FDCA?314
  • Q 7.24 : Should a company respond to a Form FDA 483?315
  • Q 7.25 : What is the discussion with management?316
  • Q 7.26 : What is “annotation” of the Form FDA 483?316
  • Q 7.27 : How does FDA determine if an inspection should result in an enforcement action?317
  • Q 7.28 : Who determines whether to issue a Warning Letter?318
  • Q 7.29 : What are inspection “close out letters”?319
  • Q 7.30 : What is the Establishment Inspection Report (EIR)?319
    • Q 7.30.1 : How do I receive a copy of my EIR?320
    • Q 7.30.2 : How do I obtain a copy of my competitor’s EIR?321
  • Q 7.31 : Are companies located outside the United States subject to FDA inspection?321
  • Q 7.32 : Are there differences between domestic (U.S.) and international (OUS) inspections?322
  • Q 7.33 : What are Accredited Third Party Inspections?322
Chapter 8: Postmarket Considerations Thomas O. Henteleff, JD ~ Kleinfeld Kaplan & Becker
Kinsey S Reagan, JD ~ Kleinfeld Kaplan & Becker
Scott M. Lassman, JD ~ Kleinfeld Kaplan & Becker LLP
  • Q 8.1 : What are the basic provisions which require the submission of adverse event information to FDA?328
  • Q 8.2 : Who must report required adverse event information to FDA?329
  • Q 8.3 : What is MedSun?329
  • Q 8.4 : Must all adverse event information be reported to FDA?330
  • Q 8.5 : What is a serious injury?330
  • Q 8.6 : When must MDRs be submitted to FDA?331
  • Q 8.7 : How do I submit MDRs?331
  • Q 8.8 : Does the submission of an MDR constitute an admission that the device at issue caused or contributed to the reportable event?338
  • Q 8.9 : Will the information in the MDR report be subject to public disclosure?338
  • Q 8.10 : Are there record-keeping requirements associated with MDRs?338
  • Q 8.11 : What are the consequences of not timely filing a required MDR?338
  • Q 8.12 : What are the basic provisions relating to recalls, notifications and reports of removals and corrections?339
  • Q 8.13 : Are all removals or field corrections subject to the section 519(f) reporting requirements?340
  • Q 8.14 : What constitutes a risk to health which would trigger a reporting obligation under section 519(g)?340
  • Q 8.15 : When must the report of removal or correction be submitted?341
  • Q 8.16 : Will information in a 519(f) report be subject to public disclosure?341
  • Q 8.17 : Are there record-keeping requirements associated with a 519(g) report?341
  • Q 8.18 : When there is a recall how does one determine the nature and scope of the recall?341
  • Q 8.19 : What regulatory requirements apply to the reprocessing of single-use devices?342
  • Q 8.20 : What are the obligations of an original equipment manufacturer that reprocesses SUDs?343
  • Q 8.21 : How does a manufacturer know if its device requires additional data?343
  • Q 8.22 : What are the basic provisions which govern the labeling and advertising for medical devices?344
  • Q 8.23 : What is a restricted device?345
  • Q 8.24 : Are all prescription devices also restricted devices?345
  • Q 8.25 : What is the significance of being subject to restricted device status?345
  • Q 8.26 : Does this mean that FDA has no jurisdiction over the content of advertisements for devices that are not restricted devices?346
  • Q 8.27 : Does all labeling for devices and all advertisements for restricted devices have to contain relevant information relating to intended uses, warnings, precautions, side effects and contraindications?346
  • Q 8.28 : Are there different requirements for different types of promotional advertising with respect to “fair balance” and “brief statement” requirements?347
  • Q 8.29 : What is an off-label use?348
  • Q 8.30 : Is a health care practitioner precluded from using a device for an off-label use?349
  • Q 8.31 : Are all communications by a company or its representatives relating to off-label uses prohibited?349
  • Q 8.32 : What are the consequences of off-label promotion?350
  • Q 8.33 : What types of changes to a PMA-approved medical device require FDA prior review and approval?350
  • Q 8.34 : What types of changes to a PMA-approved medical device do not require prior review and approval by FDA?351
  • Q 8.35 : What is “real-time review”?352
  • Q 8.36 : What types of changes to a 510(k)-cleared medical device require FDA prior review and clearance?352
  • Q 8.37 : When are postmarket studies required for an approved or cleared medical device?353
  • Q 8.38 : What is postmarket surveillance?353
  • Q 8.39 : What is device “tracking”?354
  • Q 8.40 : What is Unique Device Identification (UDI)?355
  • Q 8.41 : Can a patient refuse tracking of his device?356
  • Q 8.42 : Are medical device manufacturers subject to requirements for registering clinical trials on a publicly accessible, government database?356
  • Q 8.43 : What is the clinical trial registry database?357
  • Q 8.44 : What is the clinical trial results database?357
  • Q 8.45 : Who is responsible for submitting clinical trial information to CT.gov in accordance with the FDAAA requirements?357
  • Q 8.46 : Do the federal reporting requirements for clinical trial registries and results databases apply to all clinical trials involving a medical device?358
  • Q 8.47 : If a device trial is being conducted in a foreign country, is the sponsor required to submit information about it to CT.gov?359
  • Q 8.48 : Do observational studies need to be submitted to CT.gov?359
  • Q 8.49 : If FDAAA requirements apply, when must a sponsor submit information about a device trial to the clinical trial registry database?360
  • Q 8.50 : What type of information must be submitted to the clinical trial registry for each “applicable device clinical trial”?360
  • Q 8.51 : Does NIH make registry information publicly available at or near the time it is submitted to CT.gov?361
  • Q 8.52 : Does the FDAAA require a sponsor to submit results information for each device study for which registry information has been submitted to CT.gov?361
  • Q 8.53 : If results information is required, when must it be submitted to CT.gov and by whom?362
  • Q 8.54 : Are there any mechanisms to delay the deadline for submission of results information?362
  • Q 8.55 : If required, what type of results information must be submitted to CT.gov for each applicable device clinical trial?363
  • Q 8.56 : Are sponsors required to update their submissions to CT.gov?364
  • Q 8.57 : What are the consequences for failure to comply with the clinical trial reporting requirements under the FDAAA?364
  • Q 8.58 : How does the government monitor compliance?365
  • Q 8.59 : What are the general registration and listing requirements?368
  • Q 8.61 : What types of establishments are subject to registration?368
  • Q 8.61 : If registration is required, when must registration information be submitted?369
  • Q 8.62 : How is registration information submitted?369
  • Q 8.63 : Is there a fee required for establishment registration?369
  • Q 8.64 : Are there any special requirements for foreign establishments?370
  • Q 8.65 : What types of establishments are subject to device listing?370
  • Q 8.66 : How and when is device listing required to be submitted?370
  • Q 8.67 : What type of information must be submitted for device listing?370
  • Q 8.68 : Do any user fees apply to medical devices?371
  • Q 8.69 : How much are the user fees?371
  • Q 8.70 : Are there reductions or waivers available for small businesses?372
  • Q 8.71 : Can several devices be bundled into one application to avoid paying multiple user fees?378
Chapter 9: International Considerations Michael S. Heyl, JD ~ Hogan Lovells US LLP
Elisabethann Wright, JD ~ Hogan Lovells International
Fabien Roy, JD ~ Hyman, Phelps & McNamara
  • Q 9.1 : Are FDA requirements the same for U.S.-produced and imported medical devices?389
  • Q 9.2 : What types of activities does FDA pursue to ensure that imports are in compliance with industry laws?389
  • Q 9.3 : What are the major risks FDA faces in regulation of imports?390
  • Q 9.4 : What requirements apply to foreign manufacturers of medical devices wishing to market their products in the United States?390
  • Q 9.5 : Under what types of conditions would imported products not be permitted to be admitted?391
  • Q 9.6 : How does the import process work?393
  • Q 9.7 : What is an “Import Alert” and how is it implemented?394
  • Q 9.8 : What other FDA initiatives assure that imports meet requirements?394
  • Q 9.9 : What are the requirements for exporting products that are legally marketed in the United States?395
  • Q 9.10 : What are the requirements for exporting products that are not legally marketed in the United States?396
  • Q 9.11 : Can a company export an unapproved device that it reasonably believes could be cleared in the United States under the premarket notification process?396
  • Q 9.12 : Can a company export an unapproved Class III device to a non-listed country?397
  • Q 9.13 : How can a company export unapproved Class III devices to listed countries?399
  • Q 9.14 : When is the provision of a simple notification necessary?400
  • Q 9.15 : How are devices exported for investigational use?401
  • Q 9.16 : What requirements apply to the importation, for later export, of components of medical devices?402
  • Q 9.17 : What are Certificates to Foreign Governments (CFG) and how does an exporting company obtain them?403
  • Q 9.18 : When adverse events occur overseas, are they reportable to FDA?420
  • Q 9.19 : Which trends have affected FDA’s international strategy?420
  • Q 9.20 : What are the benefits of standards for domestic and global public health?423
  • Q 9.21 : How does FDA increase its ability to share with foreign counterparts?424
  • Q 9.22 : How do arrangements affect the establishment of a joint implementation work strategy?425
  • Q 9.23 : What are mutual recognition agreements?427
  • Q 9.24 : What is the Global Harmonization Task Force (GHTF)?428
  • Q 9.25 : What are features of a medical device regulatory system?430
  • Q 9.26 : How are clinical trials outside the United States conducted?431
  • Q 9.27 : What are the three main directives concerning medical devices in the European Union?431
  • Q 9.28 : How is a medical device defined?432
  • Q 9.29 : How would “New Approach” directives help to streamline the approval process?433
  • Q 9.30 : What is a notified body and how is it selected as having technical qualifications?434
  • Q 9.31 : What do EU Directives require of a European Authorized Representative?435
  • Q 9.32 : What will classification of its product allow a manufacturer to do?436
  • Q 9.33 : Are standards voluntary?437
  • Q 9.34 : When may medical devices be placed on the EU market?438
  • Q 9.35 : What does the CE represent?440
  • Q 9.36 : What is the relevance of a CE Mark to FDA’s premarket review process?441
  • Q 9.37 : Which key regulatory documents govern clinical trials?441
  • Q 9.38 : What does the Directive 2007/47/EC amendment address?443
  • Q 9.39 : What additional changes to the medical devices rules are expected in the coming years?444
  • Q 9.40 : What has the EU reaction been to the Poly Implant Prothèse scandal?445
  • Q 9.41 : What do the EU Demarcation Guidelines explain?447
  • Q 9.42 : What is a drug-delivery device?448
  • Q 9.43 : How is a medical device incorporating, as an integral part, an ancillary medicinal substance CE marked?448
  • Q 9.44 : How can I decide whether my product is a medical device or a medicinal product?449
Chapter 10: Interacting with FDA William H. Kitchens, JD ~ Arnall Golden Gregory LLP
Alan G. Minsk, JD ~ Arnall Golden Gregory LLP
  • Q 10.1 : How should one address general questions about the regulation of medical devices with FDA?459
  • Q 10.2 : Are there any precautions to take before directing a question to FDA?459
  • Q 10.3 : Is it appropriate to communicate directly with a reviewer or division director?460
  • Q 10.4 : Are anonymous calls to FDA permitted?460
  • Q 10.5 : Can one request an informal conference or meeting?460
  • Q 10.6 : If a company is trying to resolve an issue or address a question related to a 510(k) or Premarket Approval (PMA) submission, who is the best person to contact?461
  • Q 10.7 : What is the best way to contact the division reviewer?461
  • Q 10.8 : What if the reviewer is unresponsive or unable to resolve the issues?461
  • Q 10.9 : How long does it take to schedule a meeting with the division?462
  • Q 10.10 : What will take place at a meeting with the division and what preparation is necessary?462
  • Q 10.11 : If the issues are not resolved after meetings with the division, does the company have any recourse?462
  • Q 10.12 : Must an individual sign an affidavit if presented one by an FDA investigator?463
  • Q 10.13 : If one does not allow an FDA investigator to review requested materials, can FDA take enforcement action?463
  • Q 10.14 : Must a company allow an FDA investigator to take photographs of records or the manufacturing site?463
  • Q 10.15 : Should one go to the District Director or FDA headquarters if the FDA investigator is asking burdensome questions?464
  • Q 10.16 : Is correspondence related to enforcement actions, corrective action, or adverse event reporting made public?464
  • Q 10.17 : What is a petition?464
  • Q 10.18 : What must a Citizen Petition include?464
  • Q 10.19 : When must FDA respond to a Citizen Petition?465
  • Q 10.20 : How can one comment on a proposed rule?465
  • Q 10.21 : When will FDA convene a Public Advisory Committee meeting?466
  • Q 10.22 : Can anyone participate in a public meeting?466
  • Q 10.23 : When does FDA announce an advisory committee meeting?466
  • Q 10.24 : How can an interested person participate in the public hearing?466
  • Q 10.25 : What happens if the person does not register to speak in advance?467
  • Q 10.26 : How long is the Public Hearing portion of each advisory committee meeting?467
  • Q 10.27 : Can FDA close to the public portions of an advisory committee meeting?467
  • Q 10.28 : What are some examples of portions of FDA advisory committee meetings that ordinarily should not be closed to the public?467
  • Q 10.29 : What is a Public Board of Inquiry?467
  • Q 10.30 : When may a company request a meeting with FDA?468
  • Q 10.31 : Are company-requested meetings considered public?468
  • Q 10.32 : When may a company contact FDA about an Investigational Device Exemption (IDE) application?469
  • Q 10.33 : What is an informal guidance meeting?469
  • Q 10.34 : What is a determination meeting request?469
  • Q 10.35 : What is an Agreement Meeting?469
  • Q 10.36 : When are hearings available?470
  • Q 10.37 : What types of hearings are available?470
  • Q 10.38 : When are Formal Evidentiary Public Hearings available?471
  • Q 10.39 : What procedures apply in Formal Hearings?471
  • Q 10.40 : What types of evidence may be presented at Formal Hearings?472
  • Q 10.41 : When are other hearing types available?473
  • Q 10.42 : What are the advantages and disadvantages of the various hearing types?473
  • Q 10.43 : May a participant appeal an initial decision issued in a Formal Hearing before that decision becomes final?474
  • Q 10.44 : What must be included in the appeal of the initial decision?474
  • Q 10.45 : Is oral argument available on appeal of an initial decision?474
  • Q 10.46 : What is the scope of review when an initial decision is appealed to the Commissioner?475
  • Q 10.47 : What are potential outcomes upon appeal to the Commissioner?475
  • Q 10.48 : What further appeal options are available once the Commissioner issues a final decision?475
  • Q 10.49 : When can a party seek judicial review of an FDA action?476
  • Q 10.50 : Who is the Ombudsman and what is the role of an Ombudsman?476
  • Q 10.51 : What types of matters does the Ombudsman handle?477
  • Q 10.52 : What else does the Ombudsman do?477
  • Q 10.53 : When a U.S. Marshal is in a company to initiate a product seizure, is there an opportunity to prevent the seizure?477
  • Q 10.54 : If FDA has issued a Notice of Violation, Warning Letter or some other enforcement correspondence, including litigation, can a company request a meeting to discuss the issues?478
  • Q 10.55 : If FDA permits a meeting or telephone request, who at FDA might be present?478
  • Q 10.56 : Are phone calls or emails considered formal communication in responding to FDA in enforcement or litigation matters?478
  • Q 10.57 : Can FDA deny a request for a meeting in a litigation or enforcement matter?478
  • Q 10.58 : Must a company respond to a product seizure, injunction or other court enforcement initiative?479
  • Q 10.59 : Is a Consent Decree negotiable?479
  • Q 10.60 : Can one seek arbitration or a third-party intermediary, other than a court, in an enforcement action?479
  • Q 10.61 : Can a third party sue FDA to take enforcement action, such as initiating a court action, against another company?479
  • Q 10.62 : In a court action, to whom does a company communicate to negotiate?479
  • Q 10.63 : How should one approach advocating a particular position to FDA?480
  • Q 10.64 : How can one gather the intelligence that will advance this type of planning?480
  • Q 10.65 : Whom should one contact to advocate a position?480
  • Q 10.66 : Are there particular advocacy strategies that are most effective?481
  • Q 10.67 : Any final suggestions?482
  • Q 10.68 : What are acceptable protocols if an issue needs to be escalated within FDA?482
  • Q 10.69 : Are there any other factors to consider concerning the chain of command?482
  • Q 10.70 : What is the Freedom of Information Act?483
  • Q 10.71 : Who can request FDA-related information from the agency under FOIA?483
  • Q 10.72 : How is a FOIA request processed?483
  • Q 10.73 : Will FDA redact confidential information from records before releasing them under FOIA?483
  • Q 10.74 : Are there exemptions to FOIA disclosure?484
  • Q 10.75 : Will FDA disclose data provided to support a marketing application?484
  • Q 10.76 : Are there fees associated with the processing of a FOIA request?484
  • Q 10.77 : Does FDA make information available online?484
Chapter 11: Enforcement and Government Investigations Relating to Medical Devices Daniel A. Kracov, JD ~ Arnold & Porter LLP
Mahnu Davar, JD ~ Arnold & Porter LLP
  • Q 11.1 : What violations of the Federal Food, Drug, and Cosmetic Act can prompt FDA enforcement?488
  • Q 11.2 : What are the sources of FDA enforcement powers relating to medical devices?489
  • Q 11.3 : What is FDA’s enforcement strategy?490
  • Q 11.4 : What factors influence FDA’s decision to bring an enforcement action?493
  • Q 11.5 : What is the extent of FDA jurisdiction over devices in enforcement matters?493
  • Q 11.6 : Does FDA have subpoena powers?493
  • Q 11.7 : Do other government agencies enforce the FDCA?493
  • Q 11.8 : How does FDA involve state authorities in enforcement actions?495
  • Q 11.9 : Under what authorities does FDA conduct inspections?495
  • Q 11.10 : What is the purpose of FDA inspections?495
  • Q 11.11 : Are inspections announced beforehand?496
  • Q 11.12 : What constitutes refusal of an inspection?496
  • Q 11.13 : What facilities and records may FDA inspect?496
  • Q 11.14 : What is the Quality Systems Inspection Technique (QSIT)?497
  • Q 11.15 : How should a company prepare for an inspection?497
  • Q 11.16 : Can information obtained in an investigation be used in criminal proceedings?498
  • Q 11.17 : Can FDA investigators take samples or photographs during an inspection?498
  • Q 11.18 : Can inspectors interview personnel?501
  • Q 11.19 : What is Form FDA 483?501
  • Q 11.20 : How should a company handle requests outside the scope of FDA authority?504
  • Q 11.21 : Must company personnel sign affidavits prepared by FDA during an inspection?504
  • Q 11.22 : What is an Establishment Inspection Report (EIR)?504
  • Q 11.23 : What policies and manuals govern FDA investigations?504
  • Q 11.24 : What is the purpose of a Warning Letter?505
  • Q 11.25 : Are Warning Letters subject to judicial review?505
  • Q 11.26 : Are Warning Letters made public?505
  • Q 11.27 : What is a Warning Letter “close-out”?505
  • Q 11.28 : Are there other forms of FDA enforcement correspondence?506
  • Q 11.29 : Can FDA issue public enforcement statements?506
  • Q 11.30 : How should companies respond to such publicity?507
  • Q 11.31 : May FDA order medical device recalls?507
  • Q 11.32 : Must a company notify FDA of a recall?508
  • Q 11.33 : What is the difference between a recall, market withdrawal and stock recovery?508
  • Q 11.34 : What kind of information is required when notifying FDA?508
  • Q 11.35 : What are the different classes of recalls?509
  • Q 11.36 : How is FDA involved in a recall?509
  • Q 11.37 : What is FDA’s authority to require notification to physicians and the public of device problems?509
  • Q 11.38 : What is an import detention?510
  • Q 11.39 : What is an import alert?510
  • Q 11.40 : How should a company respond to an import detention?510
  • Q 11.41 : Under what conditions can a refused product be permitted to enter?511
  • Q 11.42 : Can uncleared/unapproved products be exported?511
  • Q 11.43 : When is a device subject to seizure?511
    • Q 11.43.1 : Who actually conducts FDA seizures?511
    • Q 11.43.2 : Against whom is a seizure action taken?511
  • Q 11.44 : What is FDA’s process for obtaining a seizure?512
  • Q 11.45 : When does FDA choose to initiate seizure actions?512
  • Q 11.46 : What is the difference between a seizure action and an injunction?512
  • Q 11.47 : Why does FDA seek injunctive relief against a company?513
  • Q 11.48 : What types of injunctions may FDA seek?513
  • Q 11.49 : When may a company be held in contempt of court for violating the terms of an injunction?513
  • Q 11.50 : What can a company do to avoid an injunction?513
  • Q 11.51 : Who may be enjoined?514
  • Q 11.52 : What is a civil money penalty (CMP)?514
  • Q 11.53 : What statute authorizes FDA to impose CMPs for violations of FDA requirements applicable to medical devices?514
  • Q 11.54 : What rules and regulations apply to small entities regarding CMPs?515
  • Q 11.55 : What are the standards for imposing a CMP?515
  • Q 11.56 : For what medical device violations may FDA not impose CMPs?515
  • Q 11.57 : What is a “significant departure” from FDA requirements that incurs a CMP?516
  • Q 11.58 : What is a “knowing departure” from FDA requirements that incurs a CMP?516
  • Q 11.59 : What is a “minor violation”?516
  • Q 11.60 : What are the limits on CMPs?516
  • Q 11.61 : What factors does FDA consider in deciding the amount of a CMP?516
  • Q 11.62 : What statutory authority does FDA have to impose CMPs regarding device clinical trials?517
  • Q 11.63 : What are the penalties for violation of clinical trials requirements?517
  • Q 11.64 : How are CMP proceedings resolved?517
  • Q 11.65 : What is the relationship between CMPs and criminal penalties?518
  • Q 11.66 : What information is sought in a criminal investigation?518
  • Q 11.67 : What is the role of FDA’s Office of Criminal Investigations (OCI)?519
  • Q 11.68 : When may the government bring a criminal action?519
  • Q 11.69 : Who files charges?520
  • Q 11.70 : What is vicarious corporate liability?522
  • Q 11.71 : What are the defenses to criminal liability?522
  • Q 11.72 : What factors will FDA consider in deciding whether to recommend prosecution?522
  • Q 11.73 : What factors will Doj consider in deciding whether to proceed with FDA’s recommendation to prosecute?523
  • Q 11.74 : When will FDA offer a company the opportunity to “present views” arguing against prosecution?523
  • Q 11.75 : What happens in a plea bargain?523
  • Q 11.76 : What is enforcement discretion?524
  • Q 11.77 : What types of penalties are available to FDA in a criminal enforcement matter?525
  • Q 11.78 : What must an organization do to have an effective compliance and ethics program?525
Chapter 12: Continuing Medical Education (CME) and Industry-Supported Scientific Activities Anthony T. Pavel, Jr ~ K&L Gates LLP
  • Q 12.1 : Does FDA regulate scientific and educational industry-supported activities?534
    • Q 12.1.1 : How do these activities differ from advertising and labeling?534
  • Q 12.2 : What are promotional activities versus nonpromotional or independent activities?535
    • Q 12.2.1 : What factors help demonstrate independence from the substantive influence of a company?536
    • Q 12.2.2 : What types of disclosure of potential conflicts of interest should be made?536
  • Q 12.3 : What is off-label promotion and how does it differ from the practice of medicine and the promotion of approved labeling indications?537
    • Q 12.3.1 : What role does education, scientific exchange and commercial free speech play?538
  • Q 12.4 : What types of industry-supported scientific and educational activities are allowable?539
  • Q 12.5 : When is a conference, symposium or other program an allowable industry-supported activity?540
    • Q 12.5.1 : What “red flags” typically lead FDA to conclude that an industry-supported activity is promotional in nature?543
  • Q 12.6 : Can sales or promotional meetings occur as an adjunct to a scientific or educational meeting?544
  • Q 12.7 : Where do specific types of educational or scientific communications by industry fit?545
    • Q 12.7.1 : What are the required elements in “disease awareness” and “help-seeking” communications?545
    • Q 12.7.2 : What are the rules regarding combination help-seeking/disease awareness ads with reminder ads or product claim promotions?546
    • Q 12.7.3 : What types of references to company name/information may be included in a help-seeking ad?548
  • Q 12.8 : What about live-case demonstrations conducted at medical and educational meetings?548
    • Q 12.8.1 : What are FDA’s principal concerns?548
    • Q 12.8.2 : Must there be “balance” in demonstrations, such as single method or product versus multiple methods or products?549
  • Q 12.9 : Can off-label indications be discussed for cleared/approved devices during product training?550
  • Q 12.10 : Are there limits on speeches or exhibits discussing devices in development or under investigation?551
  • Q 12.11 : What are acceptable promotional activities during trade shows for products not yet cleared or approved?551
  • Q 12.12 : Are there disclosures that can “cure” the display or advertisement of a device that has not received clearance or approval from FDA?552
  • Q 12.13 : What constitutes appropriate dissemination of scientific journal articles and reprints?552
  • Q 12.14 : How is the analysis different if the article discusses an off-label use of the company’s product?554
  • Q 12.15 : What type of information should accompany distribution?555
  • Q 12.16 : What are some examples of voluntary guidelines that have been developed and current trends in this area?557
  • Q 12.17 : What are the considerations for incorporation of voluntary codes of conduct into company procedures?558
  • Q 12.18 : Are there additional considerations at the state level?558
  • Q 12.19 : Can industry provide educational grants or other charitable donations to support the development of an educational conference or program?559
Chapter 13: Intellectual Property Considerations for Medical Device Companies Ronda P. Moore, DVM, JD ~ Burns & Levinson, LLP
Christine C. Vito, PhD, JD ~ K&L Gates LLP
  • Q 13.1 : What are intellectual property assets?566
    • Q 13.1.1 : What is a patent?566
    • Q 13.1.2 : Are patents granted for an idea?567
    • Q 13.1.3 : Does a patent authorize the patent holder to make and sell the patented invention?567
    • Q 13.1.4 : What is a trade secret?567
    • Q 13.1.5 : How is a trade secret different than a patent?568
  • Q 13.2 : What are the major concerns of a medical device company in creating and accumulating intellectual property assets?568
  • Q 13.3 : What are the major factors that a medical device company should address before seeking patent protection of an innovation?568
  • Q 13.4 : When is an innovation patentable?569
    • Q 13.4.1 : What is the “utility” or usefulness requirement of an invention?569
    • Q 13.4.2 : What is the novelty requirement?569
    • Q 13.4.3 : When is a U.S. patent not available under the novelty requirement?569
    • Q 13.4.4 : What does the non-obvious requirement for patentability mean?572
  • Q 13.5 : Is there a term of enforceability for a U.S. patent?573
  • Q 13.6 : How important is maximizing the patent term for most medical devices?574
  • Q 13.7 : What does “patent pending” mean?575
  • Q 13.8 : Is the innovation commercially useful and does marketing the invention incur any risks?575
  • Q 13.9 : What technology market trends is the company pursuing and will intellectual property assets increase market share in these areas?575
  • Q 13.10 : What costs should be considered before seeking patent protection?576
  • Q 13.11 : What are the costs for obtaining patent protection in the United States?576
  • Q 13.12 : What are the costs for obtaining patent protection outside the United States?576
  • Q 13.13 : How should the medical device company plan for the cost of obtaining patent protection?577
  • Q 13.14 : Is there any way a company could obtain a filing date but delay the cost of patent prosecution?578
  • Q 13.15 : Should the medical device company request a patentability search and analysis before committing the company’s resources to seek patent protection?579
  • Q 13.16 : From a competitor’s perspective, can the patented technology be “designed around”?580
  • Q 13.17 : Does a competitor have acceptable alternatives to the claimed invention?580
  • Q 13.18 : Are there any dominant patents owned by the medical device company’s competitors?581
  • Q 13.19 : How can the medical device company avoid infringing a third-party patent during the development of a new product or process?582
  • Q 13.20 : If the company develops a technology that is not commercialized by the company, is it useful to a competitor?582
  • Q 13.21 : Does the company own the patent outright or does the company share rights to the patented technology?583
  • Q 13.22 : What are employee rights to the company’s inventions?583
  • Q 13.23 : What rights to technology does the medical device company have in a joint development agreement or when the development of a technology is outsourced?583
  • Q 13.24 : What are the duties of the holder of patent rights?584
  • Q 13.25 : What is the equitable duty of candor and good faith before the Patent Office?584
  • Q 13.26 : What affirmative duties of the patent holder are required after the patent issues?585
  • Q 13.27 : Must a patented product be marked with the U.S. patent number to be enforceable against a third party?586
  • Q 13.28 : How are products marked with the patent number?586
  • Q 13.29 : After a patent issues, what conduct of the patent holder may arise in an equitable defense to patent infringement by the infringer?587
  • Q 13.30 : What types of patents other than utility patents are available to the medical device company?588
  • Q 13.31 : What does a design patent cover?589
  • Q 13.32 : What factors should be considered in deciding where to seek patent protection?589
  • Q 13.33 : May the patent application be outsourced to firms outside the United States?590
  • Q 13.34 : Why should the medical device company file patent applications outside the United States?590
  • Q 13.35 : When and how should the medical device company file patent applications outside the United States?591
  • Q 13.36 : When should the medical device company be concerned about the intellectual property rights of others?593
  • Q 13.37 : What may the medical device company do when faced with third-party dominant patents?593
  • Q 13.38 : What can the medical device company do to minimize the risk of infringing third-party patents?593
  • Q 13.39 : What is a freedom-to-operate opinion?594
  • Q 13.40 : What limitations are inherent in FTO opinions?595
  • Q 13.41 : What recourse does the company have if the FTO opinion is unfavorable and patents are found that appear to be infringed?595
  • Q 13.42 : What is a trade secret?596
  • Q 13.43 : What is the disadvantage of a trade secret?596
  • Q 13.44 : What is the advantage of a trade secret?597
  • Q 13.45 : What is required of the company to enforce a trade secret?597
  • Q 13.46 : What is an intellectual property asset?598
  • Q 13.47 : What are the basic techniques for managing patent-related assets?598
  • Q 13.48 : What are the company’s other intellectual property assets?600
  • Q 13.49 : How can effective asset management be institutionalized?602
    • Q 13.49.1 : What are examples of preventable losses?603
  • Q 13.50 : What are the possible consequences of ineffective asset management?606
  • Q 13.51 : Why does ownership matter?606
  • Q 13.52 : What happens when there is a failure to assign to the company?607
  • Q 13.53 : Is the company’s business protected?608
  • Q 13.54 : Why should the company’s patents correspond to the company’s business?608
  • Q 13.55 : What can happen if there is a disconnect between a company’s products and patents?608
    • Q 13.55.1 : How can this scenario be avoided?609
  • Q 13.56 : How can the company assess whether it is at risk in the marketplace?610
    • Q 13.56.1 : How can a company monitor for risks posed by third-party patents?610
  • Q 13.57 : What is the threshold determination for enforceability?611
  • Q 13.58 : What are the next steps in determining infringement risk?611
  • Q 13.59 : What constitutes an internal audit?612
  • Q 13.60 : What are the objectives of an IP audit?613
  • Q 13.61 : What is the audit process?613
  • Q 13.62 : What are the possible outcomes?614
  • Q 13.63 : What is the role of the company?615
  • Q 13.64 : What is the role of company counsel?615
Chapter 14: Licensing, Product Development and Commercialization Ron Ginor, MD ~ Becker & Associates Consulting, Inc
Himanshu Kashyap, MD, MBA ~ Becker & Associates Consulting, Inc
Jeff Harmes, JD ~ Kracher Harmes LLP
Susan P. Altman, JD ~ K&L Gates LLP
  • Q 14.1 : What contracts are involved in the life cycle of a medical device?618
  • Q 14.2 : What laws may apply to contracts relating to medical devices?620
  • Q 14.3 : What intellectual property rights are involved in various contracts affecting medical devices?620
  • Q 14.4 : When should a company use a licensing arrangement?621
  • Q 14.5 : When is a licensing agreement required?623
  • Q 14.6 : How is the scope of a license grant determined?623
  • Q 14.7 : What are some specialized types of licenses?626
  • Q 14.8 : When can licenses be sublicensed or assigned?627
  • Q 14.9 : What are typical licensing fee arrangements?628
  • Q 14.10 : What are other common provisions in a license pertaining to medical devices?632
  • Q 14.11 : What special provisions do patent licenses contain?634
  • Q 14.12 : What is the effect of bankruptcy on intellectual property licenses?635
  • Q 14.13 : When should I use non-disclosure agreements?636
  • Q 14.14 : What are the critical components of a non-disclosure agreement?637
  • Q 14.15 : Who owns employee-developed inventions?638
  • Q 14.16 : How should parties allocate ownership of jointly developed intellectual property?639
  • Q 14.17 : Are there alternatives to joint ownership of jointly developed intellectual property?641
  • Q 14.18 : Why would I want to license technology from a university?641
  • Q 14.19 : How can I obtain rights to intellectual property owned by a university?642
  • Q 14.20 : What is the Bayh-Dole Act and how does it affect university licensing activities?643
  • Q 14.21 : How are potential conflicts of interest for university faculty managed?644
  • Q 14.22 : What liability provisions are typical in intellectual property licenses from universities?645
  • Q 14.23 : Do licenses from universities typically include due diligence milestones?646
  • Q 14.24 : Who owns the intellectual property developed as a result of university research sponsored by a private entity and how is it licensed or commercialized?646
  • Q 14.25 : Who owns future improvements on inventions licensed from universities?647
  • Q 14.26 : What about publication of research results?648
  • Q 14.27 : How do universities treat confidential information?648
Chapter 15: Fraudulent and Abusive Practices in the Reimbursement for Medical Devices Patricia C. Shea, JD ~ K&L Gates LLP
  • Q 15.1 : What is “reimbursement”?652
  • Q 15.2 : Who are the “payors”?652
  • Q 15.3 : How does CMS make reimbursement decisions regarding medical devices?653
  • Q 15.4 : How does CMS determine whether a medical device is reasonable and necessary?653
  • Q 15.5 : Will CMS reimburse for devices that are still in development?654
    • Q 15.5.1 : What are Category B devices?655
    • Q 15.5.2 : What are Category A devices?655
  • Q 15.6 : Will CMS reimburse for the use of investigational devices?656
  • Q 15.7 : Are FDA decisions definitive for CMS reimbursement purposes?656
  • Q 15.8 : How are claims for medical devices processed to ensure consistency and efficiency?657
  • Q 15.9 : What is fraud?657
  • Q 15.10 : What does reimbursement have to do with fraud and abuse?658
  • Q 15.11 : How do federal laws governing reimbursement affect medical device manufacturers?659
  • Q 15.12 : How do a medical device manufacturer’s promotional practices implicate fraud and abuse laws?659
  • Q 15.13 : How can a medical device manufacturer’s financial relationships with healthcare providers implicate fraud and abuse laws?659
  • Q 15.14 : How can medical device manufacturers be implicated in laws designed to curb fraudulent and abusive reimbursement practices if the reimbursement flows to the healthcare provider?660
  • Q 15.15 : What laws are most likely to affect medical device manufacturers in the context of reimbursement from Medicare and other federal healthcare programs?661
  • Q 15.16 : What is the FCA?661
  • Q 15.17 : What does “knowingly” mean?661
  • Q 15.18 : What is a “claim” in the context of the FCA?662
  • Q 15.19 : What statements are “material” to a false or fraudulent claim?662
  • Q 15.20 : What are the penalties for violating the FCA?662
  • Q 15.21 : Who brings an action under the FCA?662
  • Q 15.22 : How does a private individual bring a FCA action?662
  • Q 15.23 : Has the government been successful in prosecuting under the FCA?663
  • Q 15.24 : What FCA claims have been brought against medical device manufacturers?663
  • Q 15.25 : What is the federal Anti-Kickback Statute?664
  • Q 15.26 : What are the penalties for violating the AKS?664
  • Q 15.27 : How does the AKS impact the activities of a medical device manufacturer?665
  • Q 15.28 : What AKS claims have been brought against medical device manufacturers?665
  • Q 15.29 : Are all financial relationships between medical device manufacturers and physicians (or other healthcare providers) illegal?666
  • Q 15.30 : How can you distinguish between acceptable and unacceptable financial relationships between healthcare providers and medical device manufacturers under the AKS?666
  • Q 15.31 : How can you obtain safe harbor protection?668
  • Q 15.32 : Which safe harbors are likely to apply in the context of financial arrangements between medical device manufacturers and healthcare providers?668
    • Q 15.32.1 : What are the requirements for the personal services safe harbor?668
    • Q 15.32.2 : What are the requirements for the investment interests safe harbor?669
  • Q 15.33 : How can a medical device manufacturer or healthcare professional assure that safe harbor protection applies?670
  • Q 15.34 : What is the Civil Money Penalty law?670
  • Q 15.35 : What constitutes a violation of the CMP law?670
    • Q 15.35.1 : What is an “item or service”?671
  • Q 15.36 : When should a person know that a claim is false or fraudulent?671
  • Q 15.37 : What are the penalties under the CMP law?671
  • Q 15.38 : Who enforces the CMP law?672
  • Q 15.39 : How could a medical device manufacturer be found to have violated the CMP law?672
  • Q 15.40 : Have CMP claims have been brought against medical device manufacturers?673
  • Q 15.41 : What state laws might apply to the same circumstances?673
  • Q 15.42 : What are state false claims acts?673
  • Q 15.43 : What are insurance fraud laws?674
  • Q 15.44 : How can state professional licensure laws apply?674
  • Q 15.45 : What other types of repercussions are there if a medical device manufacturer is found to have violated one of the federal or state laws discussed?675
  • Q 15.46 : What best practices can a medical device manufacturer employ in avoiding violation of the fraud and abuse laws?675
  • Q 15.47 : What are some examples of best practices?676
Chapter 16: HIPAA's Impact on the Medical Device Manufacturing Community Patricia C. Shea, JD ~ K&L Gates LLP
  • Q 16.1 : What are the major challenges HIPAA presents to a medical device manufacturer?680
  • Q 16.2 : When does HIPAA apply to a medical device manufacturer?681
  • Q 16.3 : What entities are subject to HIPAA?681
  • Q 16.4 : Why is it important to know if you are a covered entity or a business associate?681
  • Q 16.5 : What are “covered entities”?681
    • Q 16.5.1 : When is a medical device manufacturer likely to be a covered entity?682
    • Q 16.5.2 : What if only a small segment of a medical device manufacturer’s business provides healthcare services?682
  • Q 16.6 : What is a “business associate”?682
    • Q 16.6.1 : Are employees of a covered entity business associates?683
    • Q 16.6.2 : When is a medical device manufacturer a business associate?683
    • Q 16.6.3 : How does a covered entity appoint a business associate?683
    • Q 16.6.4 : What is a business associate agreement?684
    • Q 16.6.5 : Is there a standard business associate agreement?684
  • Q 16.7 : What health information does HIPAA protect?684
    • Q 16.7.1 : What does “individually identifiable health information” mean?684
    • Q 16.7.2 : How does HIPAA define “healthcare”?685
  • Q 16.8 : What does protected health information include?685
  • Q 16.9 : What are the penalties for noncompliance?685
    • Q 16.9.1 : What are the civil penalties?685
    • Q 16.9.2 : When do criminal penalties apply?687
    • Q 16.9.3 : What are the criminal penalties?687
  • Q 16.10 : What are the rules for safeguarding protected health information?687
  • Q 16.11 : What is the Privacy Rule?688
    • Q 16.11.1 : When does the Privacy Rule allow using or disclosing protected health information?688
    • Q 16.11.2 : When does the Privacy Rule require the use or disclosure of protected health information?688
    • Q 16.11.3 : When are covered entities permitted to disclose protected health information?688
    • Q 16.11.4 : What are the limits on the amount of protected health information the Privacy Rule allows to be used or disclosed?689
    • Q 16.11.5 : What does “minimum necessary” mean?690
    • Q 16.11.6 : What are “limited data sets”?690
    • Q 16.11.7 : What if a limited data set does not provide enough information for the intended use or disclosure?691
    • Q 16.11.8 : Are there any exceptions to the “minimum necessary” requirement?692
    • Q 16.11.9 : What rights does HIPAA give individuals regarding their protected health information?692
    • Q 16.11.10 : What responsibility does a covered entity have to inform individuals of these rights?692
    • Q 16.11.11 : What information must the Notice of Privacy Practices include?693
    • Q 16.11.12 : What obligation does a medical device manufacturer have for producing a Notice of Privacy Practices?693
    • Q 16.11.13 : What policies and procedures does the Privacy Rule require?693
    • Q 16.11.14 : Who is responsible for overseeing a covered entity’s compliance with the Privacy Rule?694
  • Q 16.12 : What is the Security Rule?694
    • Q 16.12.1 : What is the difference between the Privacy Rule and the Security Rule?695
    • Q 16.12.2 : How does the Security Rule apply to a medical device manufacturer?695
    • Q 16.12.3 : How does a medical device manufacturer know what safeguards it must adopt?695
    • Q 16.12.4 : What are “addressable” safeguards?696
    • Q 16.12.5 : What are “required” safeguards?696
    • Q 16.12.6 : What are the three categories of required and addressable safeguards in the Security Rule?696
    • Q 16.12.7 : What are “administrative safeguards”?696
    • Q 16.12.8 : What are “physical safeguards”?699
    • Q 16.12.9 : What are “technical safeguards”?700
    • Q 16.12.10 : Who has overall responsibility for complying with the Security Rule?702
  • Q 16.13 : What challenges does HIPAA present to a medical device manufacturer conducting research?702
  • Q 16.14 : What are the methods by which a medical device manufacturer can obtain protected health information from covered entities?702
  • Q 16.15 : What are “authorizations”?702
    • Q 16.15.1 : What information must be included in an authorization?703
    • Q 16.15.2 : What are the core elements of an authorization?703
    • Q 16.15.3 : What are the required statements?703
    • Q 16.15.4 : How do authorizations compare to “consents” that may otherwise be required in order to conduct research?704
    • Q 16.15.5 : Whose responsibility is it to get the authorization?704
    • Q 16.15.6 : Can a medical device manufacturer share the information with the sponsor of a clinical trial or others?705
  • Q 16.16 : Are authorizations always required?705
  • Q 16.17 : How do researchers get waivers of the authorization requirement from an IRB or a privacy board?705
    • Q 16.17.1 : Who has to be on the IRB or privacy board?706
    • Q 16.17.2 : What are the criteria for getting a waiver of the authorization requirement from the IRB or privacy board?706
    • Q 16.17.3 : What constitutes “minimal risk”?707
    • Q 16.17.4 : How much protected health information would be available if a waiver of the authorization requirement is satisfied?707
    • Q 16.17.5 : What documentation must exist regarding the waiver of the authorization requirement?707
  • Q 16.18 : What are the requirements for reviewing protected health information that is preparatory to research?708
  • Q 16.19 : What are the requirements for getting a waiver of the authorization requirement when the information relates to decedents?708
  • Q 16.20 : What if the researcher only needs aggregated data?709
    • Q 16.20.1 : What is “de-identified information”?709
    • Q 16.20.2 : How do you get de-identified information?709
    • Q 16.20.3 : What information must be removed?709
    • Q 16.20.4 : Why is de-identified information not protected by HIPAA?711
  • Q 16.21 : What is the difference between a limited data set and de-identified information?711
    • Q 16.21.1 : When can a researcher use a limited data set?711
    • Q 16.21.2 : What is a “data use agreement”?711
    • Q 16.21.3 : What terms must a data use agreement include?712
  • Q 16.22 : What is a “breach” of protected health information?712
    • Q 16.22.1 : When is protected health information “compromised”?713
    • Q 16.22.2 : Are there situations where the unauthorized acquisition, access, use or disclosure of unsecured protected health information is not a breach?713
  • Q 16.23 : How do you know when a breach occurs?714
  • Q 16.24 : What should a medical device manufacturer do if a breach occurs?714
    • Q 16.24.1 : What mitigation steps are required?715
    • Q 16.24.2 : When is notification required?715
    • Q 16.24.3 : What is “unsecured” protected health information?715
    • Q 16.24.4 : What technologies and methodologies has HHS specified?716
    • Q 16.24.5 : Does adopting HHS standards and methodologies allow a medical device manufacturer subject to HIPAA to avoid other laws or regulations that otherwise require notification?717
    • Q 16.24.6 : What if the information is in the form of a limited data set?717
    • Q 16.24.7 : What are a medical device manufacturer’s obligations regarding notification?717
    • Q 16.24.8 : What should the notification say?718
    • Q 16.24.9 : Where do you send the notice?719
    • Q 16.24.10 : What if current contact information for the affected individuals is not available?719
    • Q 16.24.11 : How is substitute notice provided?719
    • Q 16.24.12 : When must notice be provided?720
    • Q 16.24.13 : What if the breach occurred at the business associate?720
  • Q 16.25 : How does HIPAA work with state laws that also protect health information?721
    • Q 16.25.1 : What is preemption?721
    • Q 16.25.2 : How does HIPAA address preemption?721
    • Q 16.25.3 : What are “contrary” laws?722
    • Q 16.25.4 : What are the exceptions?722
    • Q 16.25.5 : What if the state law touches on the same subject but is not contrary to the federal law?723
  • Q 16.26 : What are examples of state laws that may preempt HIPAA?723
    • Q 16.26.1 : How would the state laws preempt?723
  • Q 16.27 : Are state laws the only ones at issue?723
  • Q 16.28 : How do you know whether you are compliant with the right laws?724
  • Q 16.29 : Does preemption apply to breach notification requirements?724
Chapter 17: Litigation, Products Liability, and Preemption Coleen Klasmeier, JD ~ Sidley Austin LLP
Rebecca K. Wood, JD ~ Sidley Austin LLP
  • Q 17.1 : What are typical products liability claims brought against the makers of medical devices?730
  • Q 17.2 : What claims have emerged in recent years?733
  • Q 17.3 : What litigation issues arise regarding the training of medical personnel to use medical devices?736
  • Q 17.4 : What potential issues arise out of company personnel being present during medical device procedures?737
  • Q 17.5 : What is the learned intermediary defense?738
  • Q 17.6 : What is the “off-label use” of medical devices?740
  • Q 17.7 : What is “off-label promotion” of medical devices and are there safe harbors for certain “off-label” communications?740
  • Q 17.8 : What litigation issues arise concerning scholarly articles about medical devices?742
  • Q 17.9 : What standards govern testimony about whether a medical device caused an injury?743
  • Q 17.10 : What is the role of “human factors” experts in medical device litigation?743
  • Q 17.11 : What is the role of foreign regulatory actions in U.S. litigation?744
  • Q 17.12 : What is spoliation?745
  • Q 17.13 : What is preemption?746
  • Q 17.14 : What is the express preemption provision of the Medical Device Amendments?747
  • Q 17.15 : Are claims involving premarket approved (PMA) medical devices and investigational device exemptions (IDEs) preempted?748
  • Q 17.16 : What claims involving PMA devices survive Riegel?749
  • Q 17.17 : Are claims involving 510(k) medical devices preempted?750
  • Q 17.18 : How do conflict preemption principles apply to medical devices?751
  • Q 17.19 : What is Buckman preemption?753
  • Q 17.20 : Beyond preemption, what state law safe harbors are available to medical device manufacturers that comply with federal standards?754
  • Q 17.21 : What has FDA said about the scope of preemption under the FDCA provisions applicable to medical devices?755
  • Q 17.22 : What factors in FDA review of a product can affect the availability of a preemption defense?757
Chapter 18: FDA Criminal Enforcement Steven M. Kowal, JD ~ K&L Gates LLP
  • Q 18.1 : What are the criminal provisions of the Federal Food, Drug, and Cosmetic Act?773
  • Q 18.2 : Does liability for an individual require participation in the “prohibited act”?774
  • Q 18.3 : Does the government prosecute individuals under the strict liability approach?775
  • Q 18.4 : Can a “prohibited act” result in felony liability?776
  • Q 18.5 : Is the government restricted to only the criminal provisions of the FDCA?777
  • Q 18.6 : Who is subject to prosecution?778
  • Q 18.7 : What causes the government to commence a criminal investigation?780
  • Q 18.8 : How important are whistleblower complaints?781
  • Q 18.9 : Who conducts the investigation?782
  • Q 18.10 : Will FDA agents be involved in the investigation?783
  • Q 18.11 : How will the investigation be conducted?784
  • Q 18.12 : Will the government contact executives and employees directly?784
  • Q 18.13 : What should an executive be advised to say and do when approached by the government?786
  • Q 18.14 : Can government agents simply seize documents and information from a company?787
  • Q 18.15 : How much evidence is needed to support a search warrant?788
  • Q 18.16 : Can a company prepare for the execution of a search warrant?789
  • Q 18.17 : Will the government conduct a grand jury investigation?790
  • Q 18.18 : Will the grand jury investigation involve testimony from individuals?791
  • Q 18.19 : Can an individual refuse to testify?791
  • Q 18.20 : What penalties can be imposed against a company?792
  • Q 18.21 : What sentence can be imposed on an individual?793
  • Q 18.22 : What conduct leads to a criminal prosecution?794
  • Q 18.23 : Can a corporation negotiate successfully once the government has decided to prosecute?796
  • Q 18.24 : Can the government insist on an agreement that controls the company’s future conduct?798
Chapter 19: Overlapping Jurisdiction with Other Agencies and Law Enforcement Entities Cathy L Burgess, JD ~ Alston & Bird LLP
Steven Niedelman ~ King & Spalding LLP
  • Q 19.1 : How is coverage and reimbursement determined for medical devices?802
    • Q 19.1.1 : Does FDA approval or clearance guarantee CMS coverage and reimbursement?803
    • Q 19.1.2 : What criteria will CMS use in making coverage determinations?803
    • Q 19.1.3 : How does CMS review medical devices?803
    • Q 19.1.4 : What does CMS require for a device to be covered?803
    • Q 19.1.5 : How does CMS code medical devices?804
    • Q 19.1.6 : How does CMS determine reimbursement for medical devices?804
    • Q 19.1.7 : How long does it take for CMS to make decisions about new medical devices?804
  • Q 19.2 : What types of medical devices are eligible for coverage and reimbursement determinations?804
    • Q 19.2.1 : Does CMS provide reimbursement for IDEs?805
    • Q 19.2.2 : What is a Category A Device?805
    • Q 19.2.3 : What is a Category B Device?805
    • Q 19.2.4 : Does CMS cover Hospital Institutional Review Board-approved IDE devices?806
    • Q 19.2.5 : Does CMS cover off-label use of medical devices?807
  • Q 19.3 : How does FTC regulation of medical devices overlap with FDA regulation?807
    • Q 19.3.1 : How is medical device labeling regulated?807
    • Q 19.3.2 : How does FDA enforce its labeling requirements?808
    • Q 19.3.3 : How does FDA determine whether a device has been misbranded?808
    • Q 19.3.4 : Is FTC responsible for regulation of all device advertising?809
    • Q 19.3.5 : How are off-label use and promotion regulated?810
    • Q 19.3.6 : How does the FTC regulate medical device advertisement?811
    • Q 19.3.7 : How does the FTC determine compliance with the FTCA?811
    • Q 19.3.8 : How does the FTC enforce the FTCA?812
  • Q 19.4 : How does FCC and FDA regulation overlap?812
    • Q 19.4.1 : How does FCC regulation of radio frequencies affect medical telemetry devices?813
    • Q 19.4.2 : What is the National Broadband Plan and how are FDA and the FCC addressing the increased use of wireless medical devices?814
  • Q 19.5 : How does EPA’s regulation of medical devices overlap with FDA’s?815
    • Q 19.5.1 : What devices are covered by EPA regulations?816
    • Q 19.5.2 : Is EPA approval required to market a pesticidal device?816
    • Q 19.5.3 : How does the EPA regulate medical devices containing or manufactured with chlorofluorocarbons and other Class I ozone depleting substances?817
  • Q 19.6 : How does OSHA regulation of medical devices overlap with FDA regulation?817
    • Q 19.6.1 : How does OSHA regulate PPE?817
    • Q 19.6.2 : How does OSHA regulate the use and cleaning of medical devices?818
    • Q 19.6.3 : How do OSHA and FDA regulate industrial prescription safety lenses?818
  • Q 19.7 : How does the Nuclear Regulatory Commission’s regulation of medical devices overlap with FDA’s?819
    • Q 19.7.1 : How does FDA regulate radiation-emitting products?819
    • Q 19.7.2 : How does the NRC regulate radioactive materials?820
  • Q 19.8 : How does DHS’s regulation overlap with FDA’s?821
    • Q 19.8.1 : What is FDA’s emergency use authorization for medical devices?821
    • Q 19.8.2 : How do FDA and the DOD regulate lasers?822
  • Q 19.9 : How does FDA work with CBP?822
    • Q 19.9.1 : How does FDA regulate imported medical devices?823
    • Q 19.9.2 : How does CBP enforce trade laws on imported medical devices?824
    • Q 19.9.3 : Who ensures that medical devices entering the United States are in compliance with FDA requirements?824
  • Q 19.10 : How are medical devices regulated under healthcare fraud and abuse laws?825
    • Q 19.10.1 : How do the OIG and the DOJ enforce the Anti-Kickback Statute?825
    • Q 19.10.2 : How do the OIG and the DOJ enforce the False Claims Act?825
    • Q 19.10.3 : Has there been recent enforcement activity by the DOJ and the OIG related to medical devices?826
  • Q 19.11 : How do SEC regulations overlap with FDA regulations?827
    • Q 19.11.1 : Does FDA review public filings and share information with the SEC?827
    • Q 19.11.2 : How do the DOJ and the SEC enforce the Foreign Corrupt Practices Act with respect to medical devices?828
    • Q 19.11.3 : Are there recent examples of FCPA enforcement against medical device manufacturers?828
  • Q 19.12 : Does FDA jurisdiction overlap with state laws?829
    • Q 19.12.1 : Does FDA coordinate with state attorneys general?830
    • Q 19.12.2 : Does FDA receive assistance from state authorities?830
  • Q 19.13 : Does FDA jurisdiction overlap with the U.S. Consumer Product Safety Commission?831
  • Q 19.14 : What does the National Advertising Review Council do?832
Chapter 20: Index to Medical Devices Law and Regulation Answer Book 2013

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