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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document describes the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility's accreditation, and/or a suspension or revocation of certificate, and/or a patient and physician notification (PPN) order. This guidance, when final, will supersede section 4.5 of the Center for Devices and Radiological Health (CDRH) Appeals Processes guidance document dated July 2, 2019. The remainder of the July 2, 2019 CDRH Appeals guidance, with exception of technical edits for consistency with the newly amended section 4.5, will not be substantively changed and will remain in effect.
A mammography facility that is in disagreement with an accreditation body's adverse accreditation or reaccreditation decision that precludes certification or recertification is entitled to appeal the decision directly to the accreditation body. If a satisfactory resolution cannot be reached with the accreditation body, the facility may request reconsideration (further appeal) of the adverse appeals decision by the Director of FDA's Division of Mammography Quality Standards (DMQS). If a facility is further dissatisfied with FDA's reconsideration decision, it may request a formal hearing before the Departmental Appeals Board, Department of Health and Human Services, as well as further review of the hearing officer's decision.
A mammography facility that wishes to challenge a suspension or revocation of an FDA certificate issued under the authority of the Mammography Quality Standards Act (MQSA) may request an informal (regulatory) hearing before the FDA as described below. The FDA has approved certain States as State Certification Agencies – or States as Certifiers (SACs) – which are responsible for certifying facilities within the state to perform mammography. In these instances, for mammography facilities that wish to challenge the suspension or revocation of a certificate issued by a SAC under the authority of the MQSA, FDA recommends presenting such challenge to their respective SAC. This document provides general information about each process, as well as guidance on how to submit related requests to DMQS.
A mammography facility that wishes to appeal a PPN order may request supervisory review (appeal) of the order under 21 CFR 10.75. The appeal should be submitted to the next level supervisor of the official who signed the PPN order.
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-2020-D-1317.