Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) released its much-anticipate report to Congress on when a modification to a 510(k) medical device triggers the need for submission of a new 510(k). In July 2011, CDRH issued draft guidance that significantly overhauled document K97-1, the Agency’s previous guidance on modifications. After significant industry pushback, FDA withdrew the guidance as part of the user fee reauthorization program in FDASIA. Section 604 of FDASIA required the Agency to issue a report to Congress explaining its approach to modifications.  The report precedes future draft guidance to be issued by CDRH following additional public input.

The key points in the report are:

  1. The core concepts of K97-1 will remain in place—an important and positive outcome for industry.
  2. CDRH will make targeted “improvements” to K97-1.
  3. CDRH will add new flowcharts and examples to its modifications guidance.
  4. CDRH will create new sections on documentation of decisions not to file a new 510(k).
  5. CDRH will prepare new draft guidance on software modifications.

The report is available here.