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Medical Device Convenience Kits - Premarket Notification and Compliance Requirements

This guidance outlines a new regulatory approach for convenience kits, aiming to reduce the regulatory burden for assemblers by potentially eliminating the need for 510(k) submissions under specific conditions. It applies to kits that are assembled for user convenience from legally marketed components.

  1. Verify if your kit type matches one listed in the guidance document
  2. Ensure all components meet the eligibility criteria (legally marketed, exempt, or 510(k) cleared)
  3. Evaluate any processing impact on kit components’ safety and effectiveness
  4. Document all determinations and maintain records per Quality System requirements
  5. Implement proper labeling identifying assembler and intended use
  6. Establish compliance with general controls (registration, listing, GMPs)
  7. For kits with drug components, contact CDER for additional requirements
  8. For kits under CBER jurisdiction, contact appropriate division for guidance
  9. Maintain documentation of sterilization validation if applicable
  10. Regular review of kit components to ensure continued compliance with marketing requirements

Key Considerations

Labelling

  • Basic labeling identifying the assembler/manufacturer and intended use(s)
  • Components should be packaged and labeled consistent with their legal marketing authorization

Safety

  • Any further processing must not significantly affect the safety or effectiveness of kit components
  • Careful consideration of sterilization impact on individual kit components
  • Special attention to components sensitive to reprocessing (e.g., surgical sutures)

Other considerations

  • 21 CFR 820: Quality System Regulation

Original guidance

  • Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
  • HTML / PDF
  • Issue date: 1997-05-19
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 965b95c6dc742a1b7bbf80ef686a5b56
This post is licensed under CC BY 4.0 by the author.