FDA Clarifies When New 510(k)s Are Required for Device Updates

The FDA issued final guidance on when to submit a new 510(k) for a planned change to an existing device.

The agency issued separate guidances for non-software changes — updated from 1997 — and for software changes, closely following draft versions issued in August 2016.

The agency took a least burdensome approach, seeking to “lower barriers to innovation and improve patient care by reducing unnecessary submissions to the FDA for changes that could not significantly affect device safety or effectiveness, so patients can benefit from upgraded products more quickly,” according to FDA Commissioner Scott Gottlieb.

The same general principles are recommended in both guidances, including determining whether the intent of the change is to significantly affect the safety or effectiveness of the existing device, and analyzing all new risks and changes to existing risks that could result from the change, using an initial risk-based assessment.