Device enhancement

Enhancements are not recalls and do not need reporting under 21 CFR 806. The difficulty is showing that the change is truly an improvement and not a fix for a problem that violates the rules.

Neither the FD&C Act nor FDA’s regulations define device enhancement. For purposes of this guidance document, a device enhancement is (1) a change to improve the performance or quality of a device that is (2) not a change to remedy a violation of the FD&C Act or associated regulations enforced by the Agency. Device enhancements include, but are not limited to, changes designed to better meet the needs of the user, changes to make the device easier to manufacture, changes to improve a non-violative device’s safety or performance, and changes to the appearance of the device that do not affect its use. A device enhancement is not a medical device recall.

FDA guidance: Distinguishing Medical Device Recalls from Medical Device Enhancements (October 2014), Section IV, Definitions and Examples