When to Submit 510(k) for a Software Change

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.

when to submit 510k software change

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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