Medical device makers lauded the FDA this week for policy proposals that would leave existing 510(k) modification rules generally intact, rather than pursuing the overhaul proposed 3 years ago.
The FDA in 2011 released guidance on changes to rules prescribing what types of modifications to already-cleared medical devices merit new FDA review. The perceived overhaul was met with consternation from medical device makers that claimed the new rules would widen the net, requiring far more modifications to undergo FDA review and further slowing the medtech regulatory process.
The federal watchdog took a step back, extended its public commenting period and ultimately addressed many of the industry’s issues, according to the new proposal.
Healthcare regulators seem have taken most of those concerns into account in drawing up the new proposals, which leave intact policy enacted in 1997. New changes include defining key terms, emphasis on validation and verification processes, guidance on reviewing materials with an eye toward protecting trade secrets and clarification of flow charts that industry can use to determine when to submit a modification application.
The FDA also added a pair of appendices to the policy, providing examples of device changes that would merit new 510(k) submissions and outlining appropriate documentation of the decision process, per industry request. Efforts to provide guidance on changes in medical device software have been set aside, to be dealt with in a separate FDA effort.
"While we are still reviewing all the details of the report, AdvaMed commends FDA for listening to our views and for the agency’s willingness to incorporate many of our recommendations in the future 510(k) modifications guidance," AdvaMed technology & regulatory affairs senior executive vice president Janet Trunzo said in prepared remarks. "Most importantly, FDA has decided to modify its existing guidance – issued in 1997 – rather than create an entirely new document. The 1997 guidance has served innovation and patients well for many years, and we agree with the agency that it should be revised and strengthened to address any areas that lack clarity or consistency."
The industry lobbing group further commended the FDA for retaining flow charts and for setting aside software changes for a later guidance.
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