Medical Devices Law and Regulation Answer Book walks you through the current regulatory requirements governing medical devices and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. The organization of this text broadly follows the typical life cycle of a device and covers a broad range of topics, including many that are not commonly included in surveys of this field.
- Overview of the legal framework of FDA regulation of medical devices
- Pre-market considerations, including clinical trials, IDEs, 510(k) and PMA submissions, 3D printed devices, devices used with regenerative therapies, combination products, restricted devices, custom devices, and radiological products
- Special FDA COVID-19 policies, emergency use authorizations, cybersecurity, laboratory-developed tests, new technologies, medical device licensing, and pandemics beyond COVID-19
- Manufacturing compliance, FDA inspections, and in vitro diagnostics
- The Quality System Regulation, post-market issues, including device promotion, adverse event reporting, and international considerations
- Interacting with FDA and government enforcement and device commercialization and related issues, including industry-supported scientific activities, intellectual property, licensing, reimbursement, privacy, product liability, preemption, criminal enforcement, and oversight by other federal agencies
With contributions from more than two dozen of the world’s leading experts in medical device regulation, this comprehensive work distills the complexities of FDA medical device regulation into a single practical guide that will be of value to virtually everyone doing business in the medical device sector — including lawyers, consultants, companies operating in the medical device sector, and individual or entity contemplating entry into this field.