Medical Device Kit Component Certification Requirements for 510k Submissions

What You Need to Know? 👇

What is kit certification for 510(k) submissions?

Kit certification is a required statement for 510(k) submissions involving medical device kits, certifying that all components are either legally marketed pre-Amendment devices, exempt from premarket notification, or have been found substantially equivalent through the 510(k) process.

When do I need to provide kit certification in my 510(k)?

You must provide kit certification when submitting a 510(k) for any medical device kit. The certification ensures all kit components have appropriate regulatory status and are not being used for new intended purposes.

What happens if I cannot certify all components in my kit?

If you cannot certify all components, you must itemize the non-compliant components and specify their regulatory status. FDA will continue premarket notification review for these uncertified components as part of your submission.

Can I use bulk components in my medical device kit?

No, components must be purchased in finished form with proper packaging and labeling consistent with their pre-Amendment, exemption, or 510(k) status. Bulk components require additional processing documentation and regulatory consideration.

What regulatory pathways qualify kit components for certification?

Components qualify if they are: (1) legally marketed pre-Amendment devices, (2) exempt from premarket notification per classification regulations, or (3) found substantially equivalent through the 510(k) process for the intended use.

How do I document additional processing of kit components?

If components undergo further processing like sterilization, repackaging, or relabeling, you must itemize these components, state their regulatory status, and describe all additional processing steps performed on each component.

---

What You Need to Do 👇

Recommended Actions

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

• 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 ID: 8ba224ed3d749b7f4aaf3197a742498c