Based on stakeholder comments raising serious concerns about a significant increase in the number of new 510(k) submissions that would be required for minor changes to 510(k)-cleared devices, CDRH Director, Jeffrey Shuren, recently signaled that the medical device center is revisiting its 27 July 2011 proposed draft guidance, 510(k) Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device. As previously reported, CDRH initially undertook a revision of the existing 1997 guidelines based on the prevalence of confusion among industry about when minor changes to a device could simply be documented internally, and when a new submission is needed. Noting that it was CDRH’s intent to bring clarity to the 1997 guidance, and not to raise the bar in terms of when a new 510(k) submission would be warranted, Shuren stated that CDRH plans to rethink the July 2011 draft based on industry comments and reissue an updated draft for comment at some point in the future. Once finalized, the updated guidance document will replace the 1997 guidelines. Shuren gave no indication, however, whether the heavily relied upon flow charts from the 1997 guidance would be making their way back into the draft.
