BME350 lecture 7

Home > Preview

The flashcards below were created by user khaengel on FreezingBlue Flashcards.


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

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

Card Set Information

Author:
khaengel
ID:
296837
Filename:
BME350 lecture 7
Updated:
2015-02-25 06:30:24
Tags:
BME350
Folders:
BME350
Description:
BME350
Show Answers:

Home > Flashcards > Print Preview