Description

The current FDA medical device enforcement climate is complex and unpredictable. Over the last several years, there has been a significant overall downward trend in the issuance of device-related Warning Letters. However, FDA has increasingly relied on the use of “non-traditional” enforcement tools. The pandemic has altered FDA’s enforcement priorities, and the reorganization and realignment of CDRH and ORA have triggered new enforcement patterns. 

Join MassMEDIC and Covington for an in-depth discussion of FDA enforcement trends in the medical device industry. We will explore FDA's current philosophy on enforcement actions, and discuss how the pandemic has impacted the agency’s enforcement posture. 

Covington's presenters are Pamela Forrest, Co-Chair of Covington's Medical Device Practice, with over 25 years of experience on a broad range of FDA regulatory issues, and Mutahar Shamsi, a non-lawyer who served 30 years at FDA in various compliance positions, including five years as FDA’s New England District Director.

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