Food and Drug Law Institute: Developments in FDA Software Regulation

Washington, DC

Epstein Becker & Green, P.C.
1227 25th St NW # 700
Washington, DC 20037

Megan Robertson and Lauren A. Farruggia, Associates, co-present "Developments in FDA Software Regulation" for the New to Food and Drug Law Group (NFDL) of the Food and Drug Law Institute (FDLI), hosted by Epstein Becker Green.

Speakers will provide an overview of the developments in FDA software regulation in the era of digital health and the 21st Century Cures Act. The presentation will include discussion of FDA’s action with respect to clinical decision-making software, bioinformatics as a part of a next-generation sequencing analysis platform, and artificial intelligence-based devices.

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