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FDA Finalizes 510(k) Guidances on When to Submit a New 510(k)

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.  These guidance documents supersede Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1), issued in 1997.

According to FDA, 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.

FDA stated that 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.

FDA also emphasizes that the final guidance and its provisions are consistent with its “least burdensome approach” for 510(k)s, which states that FDA “shall only request information that is necessary [and] shall consider the least burdensome means of demonstrating substantial equivalence.”

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