Violation or violative

Whether a device is violative decides if an action is a recall or a product enhancement. FDA's guidance on distinguishing recalls from enhancements uses this as its starting test.

For purposes of this document, violation and violative mean that the device does not comply with the FD&C Act or associated regulations enforced by the Agency.

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