FDA POSTMARKET SURVEILLANCE FINAL GUIDANCE & IMPLICATIONS FOR DEVICE MANUFACTURERS

After several years of planning and debate, the FDA recently released the final guidance on medical device postmarket surveillance studies, formally known as “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act”. The guidance finalizes a draft guidance issued in 2011 and supersedes a final guidance issued in 2006. The guidance provides device manufacturers with greater insight surrounding FDA postmarket surveillance study requirements, including when FDA is authorized to mandate a study, recommendations for the content to include in a surveillance plan, and the regulatory review process of such plans. While the final guidance remains largely unchanged from the drafted 2011 guidance, manufacturers must fully understand and be ready to comply with these new requirements. Topics to be covered in this webinar include:

• Overview of FDA’s section 522 authority
• Surveillance plan design recommendations, approval, and changes
• Key due dates and deliverables under 522
• Exemptions and appeals processes
• Failure to comply and regulatory enforcement

Speakers:
Mahnu Davar
Partner
Arnold & Porter LLP

Abeba Habtemariam
Associate
Arnold & Porter LLP

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com