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BME350 lecture 7

  1. FDA Functions
  2. FDA General information
  3. CBER

    CDER
  4. Consumer Protection: Premarket, Postmarket
  5. What does the FDA regulate:
  6. FDA Regulatory process-flow
  7. CDER (Drugs)-flow
  8. CBER (Biologics)-flow
  9. What is considered a biologic by CBER (Biologics)
  10. CDRH Device Classification
  11. CDRH Device Classification & Controls Required
  12. CDRH (Devices)-Controls(2)/PMA
  13. Class I and II CDRH Devices; 510(k) Clearance:
  14. Premarket Notification (510(k))-Class I and II
  15. Premarket Approval (PMA)->CDRH-Class III
  16. Regulatory Process
  17. Clinical Trials-IND/IDE
  18. Institutional Review Board (IRB)-purpose
  19. Clinical Trials-Phases
  20. Clinical Trials (Phase I)
  21. Clinical Trials (Phase II)
  22. Clinical Trials (Phase III)
  23. Clinical Trials-NDA/PLA/PMA
Author
khaengel
ID
296837
Card Set
BME350 lecture 7
Description
BME350
Updated

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