Post Marketing Issues for Medical Devices: An Introduction
Learn how medical device manufacturers are required to evaluate and report post-market adverse events and product problems. Recognize when to conduct a recall and how corrections and removals are reported to the FDA. Understand how medical device manufacturers are required to monitor device performance following clearance or approval.
Lauren Farruggia, Associate, Goodwin Procter LLP
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2023.
LAUREN FARRUGGIA is an associate in Goodwin’s Technology and Life Sciences groups and a member of the firm’s FDA regulatory practice. She counsels pharmaceutical, biologic, medical device, digital health, and consumer product companies on FDA regulatory compliance issues, including advertising, promotion, and labeling review, drafting and review of standard operating procedures, drug and device development issues, interactions with FDA, internal corporate investigations, and responding to FDA inspection observations and enforcement actions. Ms. Farruggia also advises FDA-regulated entities in corporate transactions, offerings, and licensing matters.Get Access
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