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On October 25, 2017, the FDA released two final guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes and complements the broader guidance document.

As medical device technology continues to evolve, these guidances are intended to provide recommendations to help manufacturers determine when an intended change to a legally marketed medical device subject to premarket notification (510(k)) requirements is significant enough to require FDA review, including changes that could significantly affect the safety or effectiveness of a device and major changes or modifications to a device’s intended use. These guidance documents supersede Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1), issued in 1997.

These final guidances build on the key concepts described in “Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1),” published January 10, 1997, with targeted changes to provide additional clarity on when a new 510(k) is needed. Changes include clarification of key terms, explanation on how to use risk assessment to evaluate whether or not a change requires a new 510(k), harmonization of flowcharts with the text of the guidance, examples of device changes that would or would not require a new 510(k), and recommendations for documenting decisions about whether or not to submit a new 510(k) for a device change.

On November 16, 2017, the FDA held a webinar for industry to discuss the final guidance documents: “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.”

Target Audience: Industry

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or at [email protected].

Food and Drug Administration
Center for Devices and Radiological Health