FDA Final Guidance: Deciding if a new 510(k) is needed

The FDA issued a new Final guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” on October 25, 2017. The full guidance is at the link provided. This supersedes the 1997 guidance. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes specifically. Deciding When to Submit a 510(k) for a Change to an Existing Device