July 22, 2020

FDA Issues Draft Guidance on MQSA Appeals Process

The Food and Drug Administration (FDA) has published draft guidance detailing the processes for mammography facilities to request additional review of an adverse appeal decision under the Mammography Quality Standards Act (MQSA). As proposed, the draft guidance would apply to adverse accreditation decisions, suspension/revocation of certificates and patient/physician notification orders. When finalized, the guidance will replace section 4.5 of the Center for Devices and Radiological Health Appeals Processes guidance document dated July 2, 2019.

The draft guidance is under review by interested ACR® Commissions, Committees and staff. Deadline for submitting comments on the draft guidance is Sept. 21, 2020.