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Recognition and Withdrawal Process for Voluntary Consensus Standards

This guidance outlines FDA's procedures for reviewing and evaluating requests for standards recognition or withdrawal of recognition. It explains the regulatory framework, policies, and practices regarding FDA's recognition and withdrawal of voluntary consensus standards for medical devices.

  1. Verify if the standard follows voluntary consensus development process with required attributes before requesting recognition
  2. Prepare complete recognition request package with all required information
  3. Contact Standards and Conformity Assessment Program before submitting request to confirm if FDA has access to the standard
  4. Monitor FDA Recognized Consensus Standards Database for updates on recognition status
  5. Plan for transition periods when standards are updated/withdrawn
  6. Consider both recognized and non-recognized versions during transition periods
  7. Document rationale for using non-recognized standards if needed
  8. Keep track of normative references within recognized standards
  9. Consider most recent FDA-recognized versions of normative references when applicable
  10. Maintain compliance with recognized standards used in submissions even after recognition withdrawal

Key Considerations

Other considerations

  • Standards must be developed through a voluntary consensus process with the following attributes:
    • Openness
    • Balance
    • Due Process
    • Appeals Process
    • Consensus
  • Recognition requests must include:
    • Requestor contact information
    • Standard title, reference number and date
    • Proposed product types for Declaration of Conformity
    • Basis for recognition
    • Brief identification of testing/performance characteristics addressed
  • FDA can recognize standards:
    • Completely
    • Partially
    • Not at all
  • FDA must make determination within 60 days of request receipt
  • Recognition can be withdrawn if:
    • Standard is replaced by new version
    • Standard is no longer appropriate for meeting requirements

      Relevant Guidances

  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
  • OMB Circular A-119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities

Original guidance

  • Recognition and Withdrawal Process for Voluntary Consensus Standards
  • HTML / PDF
  • Issue date: 2020-09-15
  • Last changed date: 2020-09-14
  • Status: FINAL
  • Official FDA topics: Medical Devices, Administrative / Procedural
  • ReguVirta summary file ID: 98705b0fe1b406e498a5094bc6b52958
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