No bad actor third party testing laboratories were specifically named in this article (other than being entities based in China and India), but it boggles the mind that a third party testing lab would generate “testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable.” It behooves an applicant for any FDA regulated product that requires third party testing lab services to know who is doing their testing, whether the data is needed as part of a FDA marketing clearance or approval process, or as is standard practice for a 510(k) exempt product.
If you don’t know a testing service, find someone you trust to help navigate the selection process for a third party testing lab. While I wholeheartedly agree with the FDA statement of “it is in the interest of sponsors and manufacturers to double-check the work of third-party test labs because they’re the ones directly affected when a device can’t be authorized due to data integrity concerns,” the reality is these third party testing documents can be very long and difficult to interpret. I’ve reviewed countless documents of these sorts on behalf of sponsors making FDA marketing submissions third party test data related to biocompatibility, electrical safety testing and immunity, coexistence testing, mechanical testing and alarms testing documents specific to certain ISO, IEC and ANSI/AAMI standards, and these documents are complex to say the least. I am not a biochemist or engineer (electrical or mechanical), so I focus on reviewing these test reports to determine if the targets are all passes, and if test fails surface, find out why something failed so we can get a sponsor on track to addressing that in a way that can make a successful marketing submission. I do not just look at the page 1 summary for a “Pass” and leave it at that.
In my experience, the search for a candidate third party testing lab is not about finding the lowest bid, but finding an outfit that is competent with good communication skills. And by competent, I mean you do need to check references, but more importantly, you have to determine the ability of testing lab to communicate their needs to you as well as field your questions effectively. If you select these test resources poorly, as FDA is warning the public, you may see a marketing submission sunk and have to start over on third party testing if you intend to resubmit to FDA. This would be costly in time, as these tests done correctly can have substantial lead times, as well as the obvious cost to having to pay someone to do it right, as well as a resubmission fee to FDA if your submission goes defunct due to statutory time constraints. Buyer beware.
