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.
What You Need to Know? 👇
What are convenience kits and when do they require 510(k) clearance?
Convenience kits are assemblies of legally marketed devices packaged together for user convenience. Under FDA’s 1997 guidance, they may be exempt from 510(k) requirements if they contain only cleared/exempt components, don’t modify intended uses, and undergo minimal processing that doesn’t affect safety or effectiveness.
Which types of convenience kits are eligible for enforcement discretion under this guidance?
The guidance includes an extensive list covering multiple specialties including anesthesiology, cardiovascular, dental, gastroenterology-urology, surgery, and others. Examples include anesthesia kits, catheter insertion trays, surgical instrument sets, and blood collection kits. The list may be periodically updated based on FDA experience.
What documentation must manufacturers maintain for convenience kits under enforcement discretion?
Manufacturers must maintain documentation supporting their determinations that kit components are legally marketed, intended uses aren’t modified, and any processing doesn’t significantly affect component safety or effectiveness. This documentation must comply with Quality System regulations (21 CFR 820) and be available for FDA review.
How should manufacturers evaluate the impact of sterilization on convenience kit components?
Manufacturers should carefully consider sterilization effects on individual components, especially sensitive items like surgical sutures. They should follow procedures described in FDA’s guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device” and take necessary measures to ensure components aren’t adversely affected.
What regulatory requirements still apply to convenience kits under enforcement discretion?
While 510(k) clearance may not be required, manufacturers must still comply with other general controls including device registration and listing, prohibition against misbranding, and good manufacturing practices. Drug components in kits remain subject to separate drug regulations requiring CDER consultation.
Does this guidance apply to all convenience kits regardless of regulatory center jurisdiction?
No, this guidance doesn’t apply to kits under Center for Biologics Evaluation and Research (CBER) jurisdiction. For CBER-regulated kits, manufacturers should contact the Office of Blood Research and Review. Drug components require separate consultation with the Center for Drug Evaluation and Research (CDER).
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 21 CFR 820: Quality System Regulation