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Acceptance Review for De Novo Classification Requests

This guidance outlines the FDA's process and criteria for conducting acceptance reviews of De Novo classification requests. It provides recommendations on the types of information necessary for FDA to conduct a substantive review of a De Novo request and explains the acceptance review process. The guidance applies to De Novo requests submitted after the effective date of the final rule on De Novo Classification Process.

  1. Complete and submit the Acceptance Checklist with the De Novo request identifying location of supporting information
  2. Ensure all required administrative elements are included:
    • Table of contents
    • Page numbering
    • Contact information
    • Device description
    • Prior submission information
  3. Provide comprehensive technical documentation:
    • Performance data
    • Test protocols and reports
    • Software documentation if applicable
    • Standards compliance information
  4. Include thorough clinical evidence if applicable:
    • Study protocols
    • Complete test reports
    • Statistical analyses
    • Compliance statements
  5. Submit complete labeling information:
    • Device description
    • Intended use
    • Directions for use
    • Required warnings/precautions
  6. Prepare detailed benefit-risk analysis and classification justification
  7. Address all applicable requirements for:
    • Sterilization/reprocessing
    • Biocompatibility
    • Electrical safety
    • Shelf life
  8. Ensure submission is for a single device type only
  9. Verify no open/pending submissions exist for same device
  10. Include financial disclosure information for clinical studies

Key Considerations

Clinical testing

  • Must include study protocols and complete test reports for each clinical investigation
  • Must provide number of investigators and subjects per investigator
  • Must include investigation design, subject selection criteria, and study population details
  • Must provide effectiveness and safety data, including adverse events
  • Must include statistical analyses results
  • Must include statements of compliance with GCP for OUS studies and 21 CFR parts 50, 56, and 812 for US studies
  • Must provide financial disclosure information for clinical investigators

Non-clinical testing

  • Must provide protocol and complete test report for each non-clinical study
  • Must include test methods, acceptance criteria, and results
  • Must provide appropriate performance testing based on device type
  • Animal studies must include GLP compliance statement or justification for non-compliance

Software

  • Must provide software level of concern and rationale
  • Must include device hazard analysis, hardware and system information
  • Must follow FDA guidance on software documentation or provide alternate approach with rationale

Labeling

  • Must include labels, labeling and advertisements sufficient to describe the device
  • Must provide directions for use
  • Must include photographs or engineering drawings where applicable
  • Must comply with 21 CFR parts 801 and 809 as applicable

Biocompatibility

  • Must identify patient-contacting components and materials
  • Must specify contact classification for each component
  • Must provide biocompatibility assessment for patient-contacting components

Safety

  • Must include electrical safety evaluation if applicable
  • Must include electromagnetic compatibility testing if applicable
  • Must provide sterilization validation if device is sterile
  • Must include shelf life testing or rationale for why not needed

Other considerations

  • IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances

Original guidance

  • Acceptance Review for De Novo Classification Requests
  • HTML / PDF
  • Issue date: 2021-10-05
  • Last changed date: 2022-02-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Biologics
  • ReguVirta summary file ID: 591a81e6dd0aa9b76886c599474df9d5
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