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FDA Postmarket Surveillance Final Guidance & Implications for Device Manufacturers
FDA Postmarket Surveillance Final Guidance & Implications for Device Manufacturers

Our Price: $395.00

Product Code: WB-7217

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About the Product
Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.

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 The guidance finalizes a draft guidance issued in 2011 and supersedes a final guidance issued in 2006.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

Mahnu Davar
Arnold & Porter LLP

Abeba Habtemariam
Arnold & Porter LLP

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
  • Regulatory Affairs
  • Postmarket Surveillance
  • Quality Assurance

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