U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders Draft Guidance for Mammography Facilities and Food and Drug Administration Staff July 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
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


Docket Number:
FDA-2020-D-1317
Issued by:
Guidance Issuing Office
Center 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.

Back to Top