AdvaMed to FDA: 510(k) rules are fine as they are

Congress is asking the FDA to tighten its policies for approving modifications of on-the-market devices, and now industry is pushing back, saying there's nothing wrong with the current process.

Under existing agency rules, devicemakers only have to re-apply for 510(k) clearance when their changes will "significantly affect the safety or effectiveness of the device," and manufacturers decide just when that is. In a whitepaper published this week, AdvaMed said that system has worked just fine in its 16 years on the books.

The FDA has yet to spell out how it plans to respond to Congress, but the industry is worried the agency will revert to a since-withdrawn draft guidance from 2011, in which the FDA proposed lowering the threshold for what kind of changes required re-clearance and putting itself in charge of making the distinction. That proposal could well have tripled the number of 510(k) applications the FDA receives, AdvaMed told MD+DI.

Since the FDA set its current 510(k) standards in 1997, "there is no indication of any widespread or systemic misuse," AdvaMed wrote, and, when problems arise, the FDA can rely on its warning letter system to force manufacturers to obtain another premarket clearance.

AdvaMed maintains that the manufacturer is still the best qualified to decide when device changes merit resubmission. But because Congress has left the FDA no choice but to amend its regulations, the trade group has some suggestions of its own to address the agency's issues with the 1997 rules. The whitepaper recommends the FDA set an established procedure for devicemakers to evaluate what constitutes a significant change, making explicit the process for testing and validating device modifications so as not to run afoul of the agency later.

But that might not be enough for the lawmakers and consumer groups alarmed by safety issues with FDA-cleared technologies.

Last summer, in the run-up to a new FDA user fee agreement, Consumers Union and other groups unsuccessfully pushed for tighter 510(k) regulations to be written into the final bill, taking issue with the fact that manufacturers can win clearance for previously recalled devices just by modifying them. In the fall, Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR) fired off a letter to CDRH asking it to make public which cleared devices were previously recalled.

- read AdvaMed's whitepaper (PDF)
- check out MD+DI's story