Submitted by kBLASTER Team on
by Morgan Lewis for JDSupra
See excerpt from commentary on Device Modifications Requiring Premarket Notification Prior to Marketing (Section 604). This is relevant to Congress revoking 2011 FDA guidance on device modifications pertinent to when it is appropriate to file new 510(k):
Device Modifications Requiring Premarket Notification Prior to Marketing (Section 604)
This provision is a response to severe industry criticism of FDA's draft guidance on device modifications requiring a new 510(k) premarket notification, which, based on an AdvaMed survey, would increase the number of 510(k)s filed anywhere from 300% to 500%. To address industry's concerns, Congress has taken the unusual step of managing FDA's issuance of this guidance document. The new law requires FDA to withdraw the draft guidance on device modifications and to follow the 1997 guidance. Moreover, FDA is prohibited from issuing a new draft guidance until after FDA prepares a report to Congress on when modifications require a new 510(k). The report must specifically address how to define certain terms used in the regulation on device modifications, what processes manufacturers should follow in making these determinations, and how to leverage the quality system to reduce the premarket burden. Further, FDA is not permitted to issue a final guidance until one year after the date of receipt of the report by Congress.