Required Documents for 510k submission

In both Traditional and Abbreviated 510(k) submissions, the FDA advises including the listed section headings in the recommended sequence. Although certain sections may not apply to your device, maintaining the specified order of headings is suggested by the FDA to facilitate expedited reviews.

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