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Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements

This guidance outlines FDA's compliance policy for the Combination Product Postmarketing Safety Reporting (PMSR) Final Rule, specifically addressing enforcement delays for certain requirements to allow manufacturers sufficient time to update their reporting and recordkeeping systems.

  1. Review and identify which reporting system(s) apply to your combination product (FAERS, eMDR, or VAERS)
  2. Develop a timeline for updating systems and procedures based on the applicable enforcement deadline
  3. Update IT systems and procedures to comply with:
    • Constituent part-based PMSR requirements
    • Submission processes for ICSRs
    • Recordkeeping requirements
  4. Implement training programs for staff on new reporting and recordkeeping requirements
  5. Monitor FDA communications for additional guidance and technical specifications
  6. Ensure compliance with non-delayed requirements under 21 CFR Part 4, Subpart B
  7. Establish a process to verify compliance with all requirements before the end of the enforcement delay period

Key Considerations

Software

  • Systems and procedures, including IT systems, must be updated to comply with reporting requirements
  • Different reporting systems (FAERS, eMDR, VAERS) have different compliance deadlines

Safety

  • Combination Product Applicants must comply with application type-based PMSR requirements
  • Constituent part-based PMSR requirements must be followed
  • Individual Case Safety Reports (ICSRs) must be submitted through appropriate systems

Other considerations

  • 21 CFR Part 4, Subpart B: Postmarketing Safety Reporting for Combination Products
  • 21 CFR 3.2(e): Combination Product Definition
  • 21 CFR 803: Medical Device Reporting

Original guidance

  • Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
  • HTML / PDF
  • Issue date: 2019-04-20
  • Last changed date: 2020-05-07
  • Status: FINAL
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: 0bf2567dec3c70b39588f7e2740c8ab7
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