Experiences with the FDA 3rd Party 510(k) Review Program
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The FDA 3rd Party Review program has been in use for many years, having been written into law in 1997. On March 12, 2020, FDA released the guidance document, "510(k) Third Party Review Program," based on the draft issued in 2018.
Under the this program, referred to as "3P510k" by FDA, 3P510k Review Organizations review a 510(k) submission and then forward their review, the 510(k) submission, and a recommendation (e.g., substantially equivalent (SE) or not substantially equivalent (NSE)) to FDA. FDA reviews the 3P510k Review Organization’s memo and recommendation and makes a final decision on the submission.
In this Live! session, we'll discuss:
- Our experiences with the 3P510k program
- The pros and cons
- Recommendations on when to use it and when to avoid it.
If you're contemplating using the program and are trying to assess the risks… great timing!
Bring your questions to the panel and we'll talk through your scenario.
- Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Counsel, R&Q
- Ruthanne Vendy — Senior Principal Specialist, R&Q
- Jessica Czamanski — Project Engineer, R&Q
- Katie Dorff — Senior Specialist, R&Q
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