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Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review

The guidance outlines FDA's procedures and criteria for assessing whether a 510(k) premarket notification submission meets minimum threshold requirements for acceptance and substantive review. It aims to ensure efficient review of complete submissions by focusing FDA resources on submissions that are administratively complete.

  1. Review submission type criteria to determine appropriate 510(k) pathway (Traditional, Abbreviated, Special)
  2. Complete applicable RTA checklist during submission preparation to ensure all required elements are included
  3. Provide clear rationale for any checklist items deemed not applicable
  4. Include acceptance checklist with submission identifying location of required information
  5. Highlight or prominently identify any changes in proposed labeling
  6. Ensure design control activities summary addresses all required elements for Special 510(k)s
  7. Submit complete test reports or declarations of conformity for any performance testing
  8. Provide clear substantial equivalence discussion comparing subject and predicate devices
  9. Include signed statements regarding design control compliance for Special 510(k)s
  10. Address any applicable device-specific guidance documents, special controls, or classification requirements

Key Considerations

Clinical testing

  • Must include completed Financial Certification/Disclosure forms for covered clinical studies
  • Must include ClinicalTrials.gov certification for applicable device trials
  • Must include statements of compliance with 21 CFR parts 50, 56, and 812 for US studies
  • Must include GCP compliance statements for OUS studies

Non-clinical testing

  • Must include summaries and full test reports of non-clinical laboratory studies
  • Must include explanation of how data supports substantial equivalence
  • For animal studies, must include protocol, final report and GLP compliance statement

Labeling

  • Must include proposed package labels and labeling (IFU, package insert, etc.)
  • Must include indications for use statement identical to 510(k) Summary
  • Must include adequate directions for use and warnings/precautions
  • Must include manufacturer name and address
  • Must include Rx statement if prescription device

Software

  • Must state software level of concern and rationale
  • Must provide documentation based on level of concern per FDA guidance

Cybersecurity

  • Must identify if device has external interfaces
  • Must provide documentation per FDA cybersecurity guidance if applicable

Biocompatibility

  • Must identify tissue-contacting components and materials
  • Must identify contact classification for each component
  • Must address relevant biocompatibility endpoints through testing or rationale

Safety

  • Must include electrical safety evaluation if applicable
  • Must include EMC evaluation if applicable
  • Must include sterilization information if provided sterile
  • Must include shelf life/stability data if applicable

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
  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Original guidance

  • Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
  • HTML / PDF
  • Issue date: 2022-04-21
  • Last changed date: 2022-04-25
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket, Biologics, Administrative / Procedural
  • ReguVirta summary file ID: 425afef65eba97e1fdd4e47a0e733b66
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