Sections Required for a Traditional FDA 510(k) Submission

The Traditional 510k submission is required for most new products and therefore is the most common type of application. The two-page summary published on the FDA website is not the complete 510k application that must be submitted to the FDA, but it is only a short summary to give general guidelines. Usually a 510(k) application is often 100 pages long, not including any applicable testing reports that could be necessary for your medical device. FDA does not publish a 510k template for you to follow in order to prepare your 510(k) submission.

Your Traditional 510k submission must consist of the following 21 sections:

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