FDA 510k

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Across
  1. 3. Medical Device Amendments enacted in 1976
  2. 4. Required for non-clinical lab studies supporting device safety
  3. 6. Device category requiring special controls
  4. 9. Standard for 510(k) clearance
  5. 11. Agency regulating medical devices
Down
  1. 1. Legally marketed device used for comparison
  2. 2. Device category subject to general controls
  3. 5. Device category typically requiring premarket approval
  4. 7. Application for high-risk devices
  5. 8. FDA finding against substantial equivalence
  6. 10. General purpose or function of a device