FDA Postmarket Surveillance Final Guidance & Implications for Device Manufacturers

1 Hour Video | Mahnu Davar and Abeba Habtemariam, Arnold & Porter LLP

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  The guidance finalizes a draft guidance issued in 2011 and supersedes a final guidance issued in 2006.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

 

Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Postmarket Surveillance
  • Quality Assurance

 

 

 

 

 

 

 

 

Mahnu Davar
Partner
ARNOLD & PORTER LLP

Mahnu Davar’s practice focuses on assisting FDA-regulated entities with complex regulatory and compliance matters. He has represented early stage medical technology companies, clinical labs, major academic research institutions, and some of the largest multinational drug and device companies in the oncology, ophthalmology, pain, and diabetes care spaces. Mr. Davar routinely counsels clients on the regulatory and compliance aspects of promotional launch campaigns, clinical research, educational grants and charitable giving, product supply chain, deal diligence, and other mission-critical activities. He has conducted significant compliance investigations and audits for business operations in the US, Europe, and Asia, and has extensive experience defending companies in criminal and civil healthcare fraud investigations.
Abeba

 

 

 

 

 

 

 

Abeba Habtemariam
Associate
ARNOLD & PORTER LLP

Abeba Habtemariam advises life sciences companies on a range of regulatory, compliance, and legislative matters, with a particular focus on counseling pharmaceutical and medical device manufacturers on compliance with the Federal Food, Drug, and Cosmetic Act. She routinely advises clients on the regulation of medical device software and healthcare IT, premarket approval and clearance strategies, promotional review matters, and cGMP compliance. Abeba also assists clients with responding to FDA and DOJ investigations and enforcement actions.

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