FDA issues new guidance on appealing decisions that adversely impact mammography accreditation
The U.S. Food and Drug Administration issued new guidance Tuesday, outlining how mammography facilities can appeal decisions that adversely impact their accreditation.
Federal officials said the instructions apply to imaging providers who have lost their accreditation status or seen their facility’s certificate suspended or revoked. Those who disagree with a decision are entitled to appeal directly to accrediting bodies, which include the American College of Radiology and the states of Arkansas, Iowa and Texas.
Imaging providers can seek further appeal from the director of the FDA’s Division of Mammography Quality Standards, when displeased with the accreditor’s verdict, the guidance noted.
“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,” the administration said March 1.
Imaging groups can also challenge the revocation or suspension of their FDA certificate by requesting an informal hearing. The Food and Drug Administration has approved certain states as certifying agencies. In such instances, the FDA recommended that imaging providers present any concerns with their status directly to the state certifier.
The FDA is accepting public feedback on its new guidance. For further information on how to comment, download the final document and read the notice in the Federal Register.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.