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DEVICE CORRECTION/REMOVAL PROPOSED RULE SHOULD INCLUDE DISCLAIMER

This article was originally published in The Gray Sheet

Executive Summary

DEVICE CORRECTION/REMOVAL PROPOSED RULE SHOULD INCLUDE DISCLAIMER statement similar to one used in both the medical device reporting (MDR) regulation and on MEDWatch forms for alerting FDA about device-related adverse events, the Health Industry Manufacturers Association says in June 21 comments to the agency. Concerned about product liability implications for manufacturers, HIMA suggests the reg carry a disclaimer "to the effect that a report submitted by a manufacturer does not necessarily reflect a conclusion by FDA or the manufacturer that the report or information constitutes an admission that the device caused or contributed to a death, serious injury, serious illness, or malfunction."
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