Summary on Format of 510(k) Premarket Notification Submission

After reading the FDA guidance for Industry and FDA staff: Format for Traditional and Abbreviated 510(k)s, a good summary on the format of an original 510(k) submission including sections and related regualtions, guidance documents, internet links which can be found in Chapter III of the guidance.

510(k) is a type of premarket submission that is intended to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device that does not require PMA. A legally marketed device is a device that was legally marketed prior to May 28, 1976, for which a PMA is not required, or a device which has been reclassified from class III to class II or I, or a device which has been found substantially equivalent through the 510(k) process. A legally marketed device is commonly known as the "predicate" device in 510(k).

FDA recommends that 510(k) submission includes the 21 sections preferaly in the sequence below:

1. Medical Device User Fee Cover Sheet (Form FDA 3601)
2. CDRH Premarket Review Submission Cover Sheet 
3. 510(k) Cover Letter
   
4. Indications for Use Statement
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. 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
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing – Bench
19. Performance Testing – Animal
20. Performance Testing – Clinical
21. Othe