510(k) Change Draft Guidance Document

After much controversy and a long wait, FDA-CDRH recently released two draft guidance documents related to making changes in 510(k) cleared devices.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The draft guidance documents are the result of a public meeting and comments to docket.

“Deciding When to Submit a 510(k) for a Change to an Existing Device”, is the more broad draft guidance, while “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”, covers the more specific software changes.