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What are all the recommended sections of a Traditional or Abbreviated 510(k) submission?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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
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