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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).

  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
  • 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.