The FDA recently released two draft guidance documents: "Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and "Deciding When to Submit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.
These draft recommendations are intended to provide guiding principles 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 warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness.
According to the FDA, these draft guidance documents are built on the process described in "Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1),” published January 10, 1997 and incorporates input from the FDA's 2013 public meeting on 510(k) device modifications and comments received in response to the FDA's Report to Congress on 510(k) device modifications. Updates in the draft guidance documents include clarifying key terms, explaining how to use risk assessment to evaluate whether or not a change requires a new 510(k), harmonization of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.