FDA issues long-awaited final guidance on when a device modification requires a new 510(k)

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the Agency) issued two final guidance documents addressing this issue on October 25, 2017.

The two guidance documents, entitled Deciding When to Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a 510(k) for a Software Change to an Existing Device, were originally issued in draft form on August 8, 2016. These guidances supersede FDA's long-standing 1997 guidance, Blue Book Memorandum K97-1, on the same topic.

The overarching regulatory standard—that a new 510(k) notice is required when a modification to a cleared device "could significantly affect the safety or effectiveness" or represents "a major change or modification in the intended use" of the device—remains unchanged. However, the final guidance documents provide a more nuanced discussion of FDA's expectations for the regulatory framework, policies, and practices underlying such a decision.

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