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Each year, the U.S. Food and Drug Administration (FDA) approves thousands of medical devices using the 510(k) pathway, an expedited process that allows manufacturers to claim “substantial equivalence” to earlier devices to get them cleared for the market sooner. Unfortunately, the 510(k) clearance pathway has enabled some products to hit the market before they were adequately tested — sometimes proving to be a misstep that backfired and led to widespread patient injuries.

Finally, the FDA is updating its requirements for the process to ensure new products “either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.”

A Memorable 510(k) Example

In 2002, Johnson & Johnson’s DePuy Orthopaedics’ metal-on-metal hip implant was one medical device that received clearance through the 510(k) process. The hip, along with similar versions from other manufacturers, has been the target of litigation after thousands of people suffered from implant corrosion and other serious problems. While similar to a separate predicate device, he cobalt and chromium components in the DePuy product had never been put together before in an implant. Marking a major design failure, the success rate for the Pinnacle implants was just 53 percent after 11 years. These problems were unforeseen, as the 510(k) clearance pathway did not require J&J to conduct clinical trials.

The age difference of the products being compared is another issue with the original 510(k) rules. Nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old. The FDA noted in a press release that older predicate devices “might not closely reflect the modern technology embedded in new devices” or a more current understanding of the benefits and risks of a device.

The Safety and Performance Based Pathway

While the changes to the rules aren’t finalized yet, the FDA plans to rename 510(k) the “Safety and Performance Based Pathway,” as it aims to emphasize objective safety and performance criteria for manufacturers to demonstrate substantial equivalence. The Agency is also increasing its expectations for the quality and quantity of information required in 510(k) submissions. It has more than doubled the amount of paperwork – now an average of 1,185 pages compared to 475 pages ten years ago.

Americans rely on the FDA to be a line of defense against dangerous devices. We’re glad to see that the Agency is planning to make the approval process stricter.

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