The USFDA (U.S. Food and Drug Administration) Center for Devices and Radiological Health provides detailed final guidance "Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders" that provide information on how mammography facilities can request additional review of an adverse appeals decision on their accreditation, a suspension or revocation of their certificate, as well as a patient and referring provider notification (PPN).
The guidance addresses how mammography facilities can appeal unfavorable decisions that affect their operations, particularly concerning their accreditation status or PPN orders, which are issued when there is a risk to public health. This guidance helps facilities navigate the process and provides clear instructions for appealing various decisions.
Mammography facilities in the United States must adhere to the standards set by the Mammography Quality Standards Act (MQSA). Accreditation is mandatory, and facilities are assessed by an Accreditation Body. Adverse accreditation decisions can arise due to non-compliance with MQSA standards, potentially leading to certificate suspension or revocation.
If a facility receives an adverse accreditation decision, it can first appeal to the Accreditation Body responsible for the decision. The process typically involves the submission of additional information to address deficiencies or inaccuracies identified during the accreditation process. Each Accreditation Body has specific procedures and timelines for filing such appeals.
If a facility’s initial appeal with the Accreditation Body is denied, the facility may request a reconsideration of the decision. This process allows the facility to present new evidence or clarification regarding the issues that led to the denial.
In cases where a reconsideration appeal is unsuccessful, the facility can escalate the appeal by requesting a regulatory hearing before the USFDA under 21 CFR Part 16. This legal framework governs formal hearings and provides the facility with an opportunity to present its case before FDA officials.
This USFDA guidance ensures that mammography facilities are given fair opportunities to appeal adverse decisions that impact their accreditation or operations. Facilities can follow structured steps to present their cases, ensuring transparency and adherence to public health standards.
For more information, you can access the full guidance document here: Appeal Options Available to Mammography Facilities (Download Full PDF)
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