510(k) Change Guidance – Update

FDA-CDRH recently released two draft guidance documents related to making changes in 510(k) cleared devices. FDA had previously released a controversial draft, but Congress passed a law, FDASIA, instructing FDA to withdraw the guidance and meet other conditions.

The draft guidance documents are the result of a public meeting and comments to docket.

“Deciding When to Submit a 510(k) for a Change to an Existing Device,” is the more broad draft guidance, while “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”, covers the more specific software changes.

The 21st Century Cures Act includes an additional provision. Section 3059(b) requires, “The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (4 U.S.C. 360(k)) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject.”