The recommended section headings included in Traditional and Abbreviated 510(k)s are listed below:

1. Medical Device User Fee Cover Sheet (Form FDA 3601)
2. CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)
3. 510(k) Cover Letter
4. Indications for Use Statement (Form FDA 3881)
5. 510(k) Summary or 510(k) Statement
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification or Disclosure Statement
9. Declaration of Conformity and Summary Reports
10. Device Description
11. Executive Summary, Predicate Comparison
12. 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