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# Guidance on CDRH’s Appeals Processes
- URL: https://www.fdaweb.com/guidance-on-cdrhs-appeals-processes/
- Published: 2022-03-01T12:00:00.000Z
- Updated: 2026-09-14T17:34:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151260

FDA has posted a [final guidance](https://www.fda.gov/media/128444/download?ref=fdaweb.com) entitled “Center for Devices and Radiological Health (CDRH) Appeals Processes” that describes the processes available to outside stakeholders to request additional review of decisions or actions by Center employees. Such individuals can request supervisory review of an action, submit a petition or request a hearing, and the document provides general information about each process, as well as information on how to submit related requests to the agency.

“The most effective means of resolving a dispute between the Center and an external stakeholder is through discussion and agreement prior to the regulatory decision,” the guidance says. “The CDRH ombudsman is available to assist in clarifying issues, mediating meetings and teleconferences, and conducting discussions with the parties in an effort to resolve disagreements before a formal request for review.“

Before contacting the ombudsman, the guidance continues, the stakeholder should have attempted to resolve the issue with a supervisor/manager. “If such attempt at resolution is unsatisfactory, it may be necessary or helpful for the relevant members of management to be brought into the discussion,” it says. “The general expectation is that the stakeholder will follow an orderly progression of interaction with Center employees followed by outreach to relevant members of management and then engagement with the CDRH Ombudsman, prior to filing a formal request for review. However, a stakeholder may file a request for review at any time that is permissible under applicable statutory and regulatory provisions.”

Additional information about the appeals process can be found in the guidance entitled, “[Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A](https://www.fda.gov/media/128447/download?ref=fdaweb.com).”