The U.S. Food and Drug Administration (FDA) released a draft guidance addressing the program that approves third parties to review premarket notification (510(k)) submissions for medical devices. The guidance is designed to speed up the approval process for medical device manufacturers, but it’s not without its shortcomings.
The guidance lists the criteria the FDA uses to consider devices for recognition, re-recognition, or the denial of recognition of a device during the 510(k) approval process. The 510(k) approval process allows new medical devices a quicker review if the products are similar other currently approved devices.
Some consumer advocates believe 510(k) approval in general is too dangerous, so the FDA’s new draft guidance has stirred up a heated debate. While third parties would only be allowed to review low-risk Class I and Class II devices, allowing third parties into the approval process could be dangerous.
Third parties could be more susceptible to bias or outside influence from medical device manufacturers. Although the FDA is trying to free up its resources to review higher-risk devices, third parties would need strict oversight to ensure their reviews meet applicable federal standards.
The 510(k) approval process is far from perfect. Devices such as Cook Medical’s Celect and Günther Tulip IVC filters were approved via the 510(k) process, but studies later revealed the devices had high rates of failure. Cook Medical is paying a high price for its use of the faster 510(k) approval process in more than 600 currently pending lawsuits.
The first case to go to trial is set to begin this month and could set an important precedent not only for other lawsuits in the Cook Medical IVC filter litigation, but also for lawsuits filed against nearly one dozen other IVC filter manufacturers.
The defective IVC filter debacle makes a strong case against utilizing not only the 510(k) approval process, but also using third party reviewers for medical device approval.