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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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