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Center for Devices and Radiological Health (CDRH) appeals processes: Guidance for industry and Food and Drug Administration staff
Center for Devices and Radiological Health (CDRH) appeals processes: Guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body. - Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, March 2, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Device Approval -- legislation & jurisprudence
Dissent and Disputes
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- 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.” The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (20 pages)).
- NLM Unique ID:
- 9918451888906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918451888906676