Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications

What You Need to Know? 👇

What are the appeal options for mammography facilities facing adverse accreditation decisions?

Facilities must first appeal to the accreditation body, then may request FDA reconsideration within 60 days. If unsatisfied, they can request a formal hearing before the Departmental Appeals Board. Facilities cannot provide mammography services during appeals.

How long do mammography facilities have to request FDA reconsideration after an adverse appeals decision?

Mammography facilities have 60 days from the accreditation body’s adverse appeals decision to submit a request for reconsideration to FDA’s Division of Mammography Quality Standards under 21 CFR 900.15.

Can mammography facilities continue operating while appealing an adverse accreditation decision?

No, mammography facilities are not permitted to provide mammography services while an adverse accreditation decision is being appealed to FDA or when their certificate is determined to be no longer in effect.

What documentation must be included when requesting FDA reconsideration of an accreditation decision?

Facilities must include the original denial, all information submitted to the accreditation body, the adverse appeals decision copy, a statement detailing disagreement bases, and relevant images in readily accessible format.

How can mammography facilities appeal a Patient and Referring Provider Notification (PPN) order?

Facilities can request supervisory review under 21 CFR 10.75 by contacting the next level supervisor within 30 days. Appeals after 60 days are denied unless good cause permits filing.

What happens if FDA immediately suspends a mammography facility’s certificate?

The suspension takes immediate effect and remains until FDA determines violations weren’t substantiated, corrections are satisfactory, or the certificate is revoked. Facilities must receive hearing opportunity within 60 days.

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What You Need to Do 👇

Recommended Actions

1. Establish internal procedures to handle potential adverse accreditation decisions or PPN orders
2. Maintain complete documentation of all communications with accreditation bodies and FDA
3. Track appeal deadlines carefully (60 days for FDA reconsideration, 30 days for PPN appeals)
4. Ensure all required documentation is included with appeal requests
5. Cease mammography services immediately if certificate is suspended or revoked
6. Follow state-specific appeal processes if certified by a SAC
7. Consider seeking legal counsel for complex appeals or when facing potential penalties
8. Maintain compliance with quality standards to prevent adverse decisions
9. Develop a communication plan for potential patient notifications
10. Keep records of all quality control measures and corrective actions taken

Key Considerations

Safety

• Facilities must meet national quality standards and be certified by FDA or a State Certification Agency (SAC)
• Facilities cannot provide mammography services while an adverse accreditation decision is being appealed
• FDA may suspend or revoke certificates if serious risks to human health are identified

Other considerations

• Facilities must first appeal adverse accreditation decisions to their accreditation body before requesting FDA reconsideration
• Requests for FDA reconsideration must be submitted within 60 days of the accreditation body’s adverse appeals decision
• PPN orders can be appealed to the next level supervisor within 30 days of issuance
• Facilities certified by SACs should follow their state’s appeal processes
• Civil money penalties and injunctions may be imposed for non-compliance

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Related references and norms 📂

• 21 CFR Part 16: Regulatory Hearing before the Food and Drug Administration
• 21 CFR Part 900: Mammography
• 42 CFR Part 498: Appeals Procedures for Determinations that Affect Participation in Medicare and Medicaid Programs

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Original guidance

• Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications
• HTML / PDF
• Issue date: 2024-09-10
• Last changed date: 2024-09-10
• Status: FINAL
• Official FDA topics: Radiation-Emitting Products, Medical Devices, Investigation & Enforcement, Radiological Health, Radiology, Administrative / Procedural
• ReguVirta ID: e7bdb7b3ea065db23e7a16c6d407c545