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# Comments on Protocol Deviations Guidance
- URL: https://www.fdaweb.com/comments-on-protocol-deviations-guidance/
- Published: 2025-03-04T12:00:00.000Z
- Updated: 2026-09-14T14:54:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158757

AdvaMed says FDA should clarify in its draft guidance on protocol deviations for clinical investigations of drugs, biological products, and medical devices that derived deviations may be used in FDA reporting of protocol deviations. In a comment [letter](https://www.regulations.gov/comment/FDA-2023-D-5016-0046?ref=fdaweb.com), the trade group also suggests defining key terms at the beginning of the document and using consistent terminology throughout it. AdvaMed also submits many technical line-by-line comments.

The Medical Device Manufacturers Association [says](https://www.regulations.gov/comment/FDA-2023-D-5016-0043?ref=fdaweb.com) it appreciates the description and explanation of the protocol deviations, but believes that additional text is needed to emphasize the difference between deviating from a protocol requirement and how all potential good clinical practice violations are not protocol deviations. It also makes specific line-by-line recommendations.