AdvaMed on the 510(k): Leave well enough alone

The FDA’s proposal to enhance regulatory oversight of modifications made to already-cleared devices ruffled some feathers among the medtech industry, which warned that more rigid oversight could triple the agency’s work without conferring much benefit to public safety.

The FDA is hosting a public meeting tomorrow to consider changes to its 510(k) modification parameters, expanding the definition of what types changes would merit a new application and re-review. The industry current operates under guidelines put in place in 1997, which AdvaMed says have proven successful in ensuring patient safety and timely review.

AdvaMed launched a comprehensive review of the 510(k) modification process last year when the FDA released a long-anticipated draft guidance entitled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”

The proposal included, among other things, exclusions for nanotechnology and in vitro diagnostic devices, more guidance on software changes and greater clarity on what types of changes merit a new 510(k), the latter raising a red flag for AdvaMed. The current guidelines grant device makers a lot of discretion in determining what types of changes they believe merit new 510(k) review, but the FDA’s new proposal is more prescriptive.

In addition to warning that the new rules could result in a much larger quantity of 510(k) submissions, AdvaMed’s year-long analysis framed the FDA’s proposal as a bit of a solution in search of a problem.

REFERENCE:  June 12, 2013 by Arezu Sarvestani; Mass Device

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