The FDA issued a final guidance entitled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device)” dated October 25, 2017. This guidance clarifies for the industry how to determine which software changes to a 510(k)-cleared device require a new 510(k). It seems to reflect what the FDA has applied in the past, but now provides a specific reference and more clarity for the decision process. It includes significant emphasis on risk assessment and provides a flowchart and a set of questions to ask to aid in the 510(k) determination. The full guidance is at the link provided. Note that FDA simultaneously released a draft revision to its general guidance for when to submit a new 510(k) for any type of change to a medical device.
