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Medical Device Kit Component Certification Requirements for 510k Submissions

This guidance outlines the certification requirements for medical device kits submitted through the 510(k) process. It specifically addresses how manufacturers should certify the regulatory status of individual components within their kits.

  1. Review all kit components and verify their regulatory status
  2. Prepare certification statement confirming components meet one of the three acceptable categories
  3. Verify all components are purchased in finished form
  4. Create itemized list of any components that don’t meet certification criteria
  5. Document any additional processing performed on components
  6. Ensure all component documentation matches their regulatory status
  7. Maintain records of component regulatory status and certifications
  8. Include complete certification documentation in 510(k) submission

Key Considerations

Labelling

  • Components must be packaged and labeled consistent with their pre-Amendments, exemption, or premarket notification criteria and status

Other considerations

  • 21 CFR 862.9: Limitations of exemptions from Section 510(k)

Original guidance

  • Medical Device Kit Component Certification Requirements for 510k Submissions
  • HTML
  • Issue date: 1997-06-30
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 8ba224ed3d749b7f4aaf3197a742498c
This post is licensed under CC BY 4.0 by the author.