Premarket Approval of Medical Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Premarket Approval of Medical Devices

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Subpart
A

General

Subpart
B

Premarket Approval Application (PMA)

Subpart
C

FDA Action on a PMA

Subpart
D

Subpart D - Administrative Review [Reserved]

Subpart
E

Postapproval Requirements

Subpart
F-G

Subparts F-G [Reserved]

Subpart
H

Humanitarian Use Devices