1-Hour Program

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Overview

On Friday, January 16th, FDA released two new proposed policies relating to mobile health—draft guidances concerning wellness products and device accessories.  This continues a trend of significant developments in the regulatory oversight of health-related software, particularly mobile apps and other applications that could be subject to regulation by FDA as a medical device. FDA’s final guidance on mobile medical applications and related policy pronouncements, and release of a proposed regulatory framework for the regulation of health IT, as mandated under FDASIA, have provided clarity as to certain types of clinical software. But many questions remain, and various regulatory issues concerning health-related software are likely to be considered in the coming year. 

Nathan A. Brown, who heads Akin Gump Strauss Hauer & Feld LLP’s FDA practice, and Bakul Patel, Acting Associate Director for Digital Health at FDA’s Center for Devices and Radiological Health, will prepare you for the coming year in FDA regulation of medical software. The session will discuss recent developments, analyze likely developments in the coming year, and offer recommendations for developers of medical software. For those companies developing medical device software and those companies developing software applications that are not subject to active regulation as a medical device, best practices can reduce risk of enforcement. 

Topics to be addressed include: 

• Analysis of the just-released proposed policies on wellness products and device accessories

• An overview of current FDA policy on mobile apps and other software

• Analysis of emerging issues in software regulation, including treatment of modifications, application of good manufacturing practices, cybersecurity considerations, treatment of clinical decision support software, and regulation of applications for self-directed care

• Considerations for companies planning to submit medical software applications for FDA clearance or approval

• Strategic factors for software applications that are not subject to premarket clearance or approval

• Application of good manufacturing practices to software

• Product lifecycle considerations for software applications

 

Credit Details