Appeal options available to mammography facilities concerning adverse accreditation decisions, suspension/revocation of certificates, or patient and physician notification orders: guidance for mammography facilities and Food and Drug Administration staff
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 supersedes section 4.5 of the Center for Devices and Radiological Health (CDRH) Appeals Processes guidance document dated July 2, 2019. 1 The remainder of the July 2, 2019 CDRH Appeals guidance, with the exception of technical edits for consistency with the newly amended section 4.5, was not substantively changed. 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.
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