FDA Guidance Recalls versus Enhancements

The FDA issued a gudance entitled “Distinguishing Medical Device Recalls from Medical Device Enhancements” dated 15-Oct-2014. This guidance provides a series of examples as well as some explanation to help distinguish recalls, corrections, removals, and enhancments of medical devices. A number of the examples are for software changes. Some general principles relate to whether the change is being made because the device does not meet its specificaitons and claims and whether the device is violative (not in compliance with FDA law/regulation).

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