If Company B discovers by any means that their own product may have a serious design flaw, the CAPA process may be a good way to investigate the extent of the problem and plan whatever actions may be appropriate - design change, discontinuation, recall, or whatever.
Company A's actions have no particular effect on Company B's product's clearance. If Company B's product is not affected by Company A's product's flaw, it can still be made available.
If company B's product is not affected, it would be a good idea to have documentation showing why not, because the question is likely to be asked at some point.
------------------------------
Anne LeBlanc
United States
------------------------------
Original Message:
Sent: 25-Feb-2022 10:40
From: Gaurang Bhavsar
Subject: Hypothetical Questions
Predicate devices that were problematic and removed from the market may still be used to demonstrate "substantial equivalence" for new devices. Also, devices that were already on the market when regulation began in 1979 were grandfathered; they may be used as a predicate even though they never had to demonstrate safety or efficacy. In 2011 the Institute of Medicine recommended eliminating the 510(K) pathway, saying it fails to protect patients. But since then, Congress has approved measures to allow more devices to use that pathway.
https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/medical-devices/
Hope above link will be helpful for your way forward with your product.
------------------------------
Gaurang Bhavsar, MS, RAC
Associate Director - Regulatory Affairs
Micro Labs USA, Inc.
Somerset, NJ 08873
USA
Original Message:
Sent: 23-Feb-2022 11:33
From: Ed Panek
Subject: Hypothetical Questions
Company A develops and manufactures a brand new type of medical device. The device is reviewed (FDA) and is made available for use in the market.
Company B submits a 510(k) using Company A device as the predicate. This device is cleared and available in market for use.
Sometime later company A notifies FDA it is withdrawing its device from the market for a serious design problem after numerous reportable events. The device is not planned to be resubmitted for marketing/sale.
May company B continue marketing and selling its device? If during its annual management review its noted under MAUDE and the 510(k) register the original device has been removed from market for safety reasons how should company B proceed?
------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------