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