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.
Recommended Actions
- Review all kit components and verify their regulatory status
- Prepare certification statement confirming components meet one of the three acceptable categories
- Verify all components are purchased in finished form
- Create itemized list of any components that don’t meet certification criteria
- Document any additional processing performed on components
- Ensure all component documentation matches their regulatory status
- Maintain records of component regulatory status and certifications
- 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
- Components must fall into one of three categories:
- Legally marketed pre-Amendments devices
- Exempt from premarket notification
- Found substantially equivalent through 510(k) process
- Components must be purchased in finished form, not in bulk
- Any components that don’t meet certification criteria must be itemized
- Any further processing of components (sterilization, packaging, labeling) must be disclosed
Relevant Guidances
- Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
- Unique Device Identification Requirements for Convenience Kits
Related references and norms
- 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.