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.
Recommended Actions
- Verify if your kit type matches one listed in the guidance document
- Ensure all components meet the eligibility criteria (legally marketed, exempt, or 510(k) cleared)
- Evaluate any processing impact on kit components’ safety and effectiveness
- Document all determinations and maintain records per Quality System requirements
- Implement proper labeling identifying assembler and intended use
- Establish compliance with general controls (registration, listing, GMPs)
- For kits with drug components, contact CDER for additional requirements
- For kits under CBER jurisdiction, contact appropriate division for guidance
- Maintain documentation of sterilization validation if applicable
- 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
- Components must be either:
- Legally marketed preamendments devices
- Exempt from premarket notification
- Found substantially equivalent through 510(k) process
- Components should be purchased in finished form
- Documentation supporting determinations must be maintained per Quality System regulation
- Compliance with general controls including registration, listing, and GMPs is required
- Does not apply to drug components or kits under CBER jurisdiction
Relevant Guidances
- Sterilization of Convenience Kits: Component Compatibility and Validation Requirements
- Unique Device Identification Requirements for Convenience Kits
- Medical Device Kit Component Certification Requirements for 510k Submissions
Related references and norms
- 21 CFR 820: Quality System Regulation
Original guidance
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