Sections and format of a 510 (k) submission

There are three types of FDA 510 (k) Premarket Notifications. The most common is the Traditional 510 (k) which is required for most new products. Many people confuse the 1-2 page "Summary" published on the FDA website with the complete application that must be submitted to the FDA. This summary is exactly what it means - a summary. A final 510 (k) application when submitted is often 50-100 pages in length, not including any applicable testing reports for your product. The FDA does not publish a template that you must follow for a 510 k submission, but it must address the 21 sections shown below.

1. Medical Device User Fee Cover Sheet
2. CDRH Premarket Review Submission Cover Sheet
3. 510 (k) Cover Letter
4. Indications for Use Statement
5. 510 (k) Summary or Statement
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification or Disclosure Statement
9. Declarations of Conformity and Summary Reports
10. Executive Summary
11. Device Description
12. Substantial Equivalence Discussion
13. Proposed Labeling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software, if applicable
17. Electromagnetic Compatibility and Electrical Safety, if applicable
18. Performance Testing – Bench, if applicable
19. Performance Testing – Animal, if applicable
20. Performance Testing – Clinical, if applicable
21. Other