15/16 February 2022
The FDA has published an independent industry guideline on product recalls, biological and medical devices ("Product Recalls, Including Removals and Corrections"). According to this guideline, the FDA requires very detailed information in cases of recalls (What type of defect? Is there some potential health hazard?, etc.). The guideline describes deficiencies which refer to regulations like for example the GMPs.
Sometimes, there are reasons for a certain "type of recall" which isn't due to a product deficiency. For example, a product currently on the market may be replaced by a newer, better one. In this case, the reason for the "recall" is product quality enhancement. In order to clearly distinguish product recalls from product enhancements, the FDA published at the end of February a draft guideline (entitled "Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements"), which is designed for both the industry and the FDA itself. The draft - composed of 15 pages - has been primarily created in a question-and-answer style. Yet, the draft begins with a chapter of definitions (What is a recall? What is product enhancement? Etc...). A decision making flow chart - whether a product recall should be made or not - finally completes the questions and answers. The draft can be commented within 90 days of publication.
Conclusion: The new draft guideline "Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements" is a useful document to better understand the sensitive issue of medical device recalls.