The guidance informs mammography facilities how they can request an additional review of an appeals decision not in their favor regarding accreditation, suspension, or revocation of a Mammography Quality Standards Act (MQSA) certificate or patient and physician notification orders.
Under the new guidance, facilities that want to challenge the suspension or revocation of an MQSA certificate can either request an informal regulatory hearing before the FDA or, if applicable, present a challenge to State Certification Agencies. Facilities that wish to appeal patient and physician notification orders should request supervisory review of the order and submit the appeal to the next level supervisor.
The FDA is accepting comments on the draft guidance through September 21. When implemented, the new guidance will replace the existing appeals processes outlined in section 4.5 of the 2019 Center for Devices and Radiological Health Appeals Processes guidance document.
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