FDA When to Submit 510(k) for a Software Change.

FDA issued a finaguidance entitled “Deciding When to Submit a510(k) for a Software Change to an Existing Device)” dated October 25, 2017. This guidance clarifies for industy how to determine what software changes to a 510(k) cleared device require a new 510(k). It seems to reflect what FDA has been applying 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 ot a medical device. Deciding When to Submit a 510(k) for a Software Change to an Existing Device

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