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Guidance Issuing OfficeCenter for Devices and Radiological Health
Section 3308 of The Food and Drug Omnibus Reform Act of 2022 (FDORA) enacted as part of the Consolidated Appropriations Act, 2023 (December 29, 2022) amended section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act. This guidance was developed and issued prior to the enactment of FDORA, and certain sections of this guidance may no longer be current as a result. FDA is assessing how to revise this guidance to represent our current thinking on this topic. For more information please contact the CDRH Ombudsman at CDRHOmbudsman@fda.hhs.gov.
This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees.
Individuals outside of the Food and Drug Administration (FDA), who disagree with a decision or action taken by CDRH and wish 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. These processes are broadly described in statutes and regulations which pertain to FDA. This document provides general information about each process, as well as guidance on how to submit related requests to CDRH and FDA.
Keep in mind as you read over this material that for any situation, multiple processes for resolution may be available. 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. 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, a stakeholder should have made reasonable efforts to discuss the decision or action in dispute with the individual charged with managing the matter at issue. 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. 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 is described in the companion guidance entitled, “Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff.”
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0893.