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launched a comprehensive review of the 510(k) modification process last year when the FDA released a long-anticipated draft guidance entitled "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device."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.
"Our review did not reveal any public health issues or systemic compliance issues that would indicate the current process is not robust or does not work," Boston Scientific (NYSE:BSX) global regulatory affairs vice president Tamima Itani said in a conference call with media today. "The 1997 guidance document has been in existence, been used for over 15 years now, providing manufacturers with a consistent, predictable tool to assist their assessment of what submissions are needed for device changes."
The white paper AdvaMed issued in advance of the FDA meeting raised the same concern, noting that "it is unclear that there is a real problem that needs to be solved." The analysis makes the argument on the grounds that the 510(k) rule that has governed medtech modifications for more than a decade, presumably oversaw hundreds of thousands of modifications without "indication of any widespread or systemic misuse," according to the white paper.
Instead AdvaMed’s analysts, which also included Roche Diagnostics (PINK:RHHBY) global regulatory counsel Danelle Miller, suggested that the current 510(k) modification rules may be strengthened without a significant overhaul.
"The current guidance isn’t perfect and we recognize it can be improved, but we’re just not aware … of any systemic problems that would call for completely eliminating this current guidance and starting over," Miller said during today’s call. "With that in mind, our recommended path forward really focuses on maintaining the current guidance … as a foundational document with some improvements."
Those improvements include language to clarify the manufacturer’s role in evaluating modifications to its medical devices and keeping records of those assessments and how 510(k) decisions are made, as well as a validation-based process by which modifications can be assessed as meeting the "significantly affecting safety and effectiveness" test that prompts further review.