|
FDA’s Warning Letter Highlights Need for Pre-Approval of Device Modifications
(Thursday, April 20, 2023) Medical device manufacturers need to re-access if their device’s FDA approval or clearance is still valid upon making modifications to the device. Not doing a proper assessment could lead to FDA deeming the device illegally marketed. This hard lesson was learnt by Abbott’s Canadian unit selling a diagnostic test for quantitative measurement of cardiac troponin I in whole blood or plasma. On top, FDA made a surprising and uncommon request, seemingly concerned by the “predicate creep” issue; FDA asked that the company “assess the cumulative effect of the changes on the device performance with the modified device compared to the original FDA approved device”. The device was originally approved in 2003 and it seems that over the years the device was modified slightly on multiple occasions. These modifications, that individually might have been considered minor, accumulated over 20 years and by the time of FDA’s inspection in the year 2022, the cumulative effect of the modifications was deemed as major changes requiring re-approval by the FDA. From the warning letter it seems the company was ill-prepared to deal with the FDA audit. The personnel could not find several key documents related to the original FDA approved device and had not conducted a formal assessment of the impact of the modification of the device for needing a new 510(k), as required by the regulations. The FDA identified four significant design changes made by the firm since 2003. Based on the missing information, FDA’s inspectors concluded that the company had made significant design changes to its device without submitting a new 510(k) and as a result the product was considered adulterated and misbranded. These seem to be self-inflicted wounds by the company’s regulatory staff. It is not uncommon that over 20 years since the device was originally approved, changes were made to the device design to accommodate user feedback and vendor changes, but those changes require adequate documentation and tracking of changes. While it is hard to predict if FDA would still have disagreed with the self-assessment of not needing a new 510k, the FDA inspector would at least not have found the company to be willfully non-compliant as is indicated by the Warning Letter. That it happened with a company like Abbott should be a warning for others; if someone like Abbott can make such a mistake, anyone can. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
|
|
|
