Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications
This guidance outlines the appeal processes available to mammography facilities regarding adverse accreditation decisions, suspension/revocation of certificates, and patient and referring provider notification (PPN) orders under the Mammography Quality Standards Act (MQSA).
Recommended Actions
- Establish internal procedures to handle potential adverse accreditation decisions or PPN orders
- Maintain complete documentation of all communications with accreditation bodies and FDA
- Track appeal deadlines carefully (60 days for FDA reconsideration, 30 days for PPN appeals)
- Ensure all required documentation is included with appeal requests
- Cease mammography services immediately if certificate is suspended or revoked
- Follow state-specific appeal processes if certified by a SAC
- Consider seeking legal counsel for complex appeals or when facing potential penalties
- Maintain compliance with quality standards to prevent adverse decisions
- Develop a communication plan for potential patient notifications
- 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
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
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 summary file ID: e7bdb7b3ea065db23e7a16c6d407c545
This post is licensed under CC BY 4.0 by the author.