Megan Robertson, Lauren Farruggia Featured for FDLI Presentation on FDA Software RegulationFDLI Update December 2018/January 2019
Megan Robertson and Lauren Farruggia, Associates in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, were featured in FDLI Update Magazine, for their presentation to the Food and Drug Law Institute's New to Food and Drug Law Group.
Below is an excerpt:
The Food and Drug Law Institute is pleased to organize and offer events for professionals who are new to the food and drug law community to learn, network, and advance their careers. The New to Food and Drug Law (NFDL) group recently held a lunch-and-learn event on “Developments in FDA Software Regulation.”
Megan Robertson and Lauren Farruggia, Health Care and Life Sciences Associates at Epstein Becker & Green, P.C., provided an overview of the developments in FDA software regulation in the era of digital health and the 21st Century Cures Act. The presentation included 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. A diverse audience attended, including representation from government, law firms, and public interest groups, which spurred a lively discussion between speakers and attendees.