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Types of FDA 510k and Submission Methods

发布时间:2022-01-16 浏览次数:3563

Traditional510k:  Most companies introducing a new Class II device must submit aTraditional 510k Premarket Notification.  This is a full submission with21 sections. FDA’s clearance of a Traditional 510k is 90 days

Special510k:  This clearance is used when there is a design change or amodification to a device you have previously cleared that does not affect theintended use.  FDA’s clearance of a Special 510k is 30 days.

Abbreviated510k:  There are specific guidelines for this 510k clearance. There has to be guidance documents from FDA for the specific medical devicethat is to be cleared.  A special control has been established by FDA forthis device and consensus standards.  FDA’s clearance of an Abbreviated510k is 90 days

FDA 510k SubmissionReqiurement

  1. Medical Device User Fee Cover Sheet
  2. CDRH Premarket Review Submission Cover Sheet
  3. 510k Cover Letter
  4. Indications for Use Statement
  5. 510k Summary
  6. Truthful and Accuracy Statement
  7. 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

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