Issued on August 8, 2016, regulatory impact includes the following:
- FDA issued the original Deciding When to Submit a 510(k) for a Change to an Existing 53 Device (K97-1) on January 10, 1997 to provide guidance on this regulatory language
- This draft guidance preserves the basic format and content of the original, with updates to add clarity
- When finalized, this document will supersede Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1), issued on January 10, 1997
Critical to the new draft guidance (and easy to overlook) is the use of “letters to file” for documentation of changes, addressed in Appendix B. If you do not believe your change documentation meets that standard set forth in the draft guidance, don’t hesitate to contact us. Click for a copy of the new draft guidance.
Issued on the same day was yet another new draft guidance entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device. Be sure and review both of these new draft guidances as you plan changes to design, packaging, labeling or software. Click here for help, and here for a copy of the new draft guidance for Software Modifications.