Speaker details

Biography

Pamela Forrest is a Partner in Covington & Burling's FDA practice, where she co-chairs Covington’s Medical Device Industry Group. She has over 30 years of experience advising clients on a broad range of FDA regulatory issues, with a specific focus on medical device and digital health matters. She advises firms on the full life-cycle of FDA medical device requirements, including pre-market review, product recalls, medical device reporting, quality system regulation compliance, inspection readiness, advertising and promotion, import/export issues, and clinical trial requirements. Pamela regularly assists medical device manufacturers and private equity firms with complex due diligence evaluations regarding the FDA compliance status of acquisition targets. She also frequently counsels start-up medical device firms on market entry strategies, and works with firms to identify the appropriate regulatory pathway and shepherd them through the FDA regulatory process. Pamela is also a recognized expert on FDA enforcement. She frequently advises medical device manufacturers on responses to FDA enforcement actions, including inspectional observations and Warning Letters. She has extensive experience working with firms to draft written responses, develop and implement corrective actions, and prepare for re-inspection.