FDA issues guidance on appeals process for mammography facilities

The U.S. Food and Drug Administration (FDA) issued final guidance for mammography facilities appealing decisions regarding adverse accreditation rulings and suspension of certificates, as well as patient and physician notification orders.

The FDA said that a facility that disagrees with an accrediting body's decisions that precludes certification or recertification is entitled to appeal directly to the accreditation body. If a resolution can't be reached, the facility can further appeal to the director of FDA's Division of Mammography Quality Standards (DMQS).

If a facility is further dissatisfied, it can request a formal hearing before the Departmental Appeals Board in the U.S. Department of Health and Human Services, as well as further review of the hearing officer's decision.

The FDA also said a mammography facility wanting to challenge a suspension or revocation of an FDA certificate issued under the authority of the Mammography Quality Standards Act (MQSA) can request a regulatory hearing before the FDA.

When it comes to appealing a patient and physician notification order, a facility can request supervisory review under 21 CFR 10.75.