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# 2 CDRH Appeals Process Guidances
- URL: https://www.fdaweb.com/2-cdrh-appeals-process-guidances/
- Published: 2019-07-08T12:00:00.000Z
- Updated: 2026-09-15T01:36:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144467

FDA has issued two guidances relating to the CDRH appeals process. The first, *Center for Devices and RadiologicalHealth (CDRH) Appeals Processes*, describes processes available to outside stakeholders to request additional review of decisions or actions by CDRH staff. The [document](https://www.fda.gov/media/128444/download?ref=fdaweb.com) notes that individuals outside FDA who disagree with a CDRH action or decision and want to have it reviewed or reconsidered have several processes for resolution from which to choose, including requests for supervisory review of an action; petitions; and hearings.

The guidance says that for any given situation, multiple processes for resolution may be available, and it is up to the party seeking review of an adverse decision or resolution of a difference of opinion to determine the appropriate process for a given circumstance or issue.

“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,” FDA says.

The second [guidance](https://www.fda.gov/media/128447/download?ref=fdaweb.com), *Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A*, uses a question-and-answer format to give the Center’s interpretation of key provisions in Section 517A of the Federal Food, Drug, and Cosmetic Act as they pertain to requests for appeals of significant decisions and for the timeframes and procedures of regulatory decisions and actions taken by CDRH under specific regulations.