Application and Administrative Action

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Investigational Device Exemptions
  7. Application and Administrative Action

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Section
812.20

Application.

Section
812.25

Investigational plan.

Section
812.27

Report of prior investigations.

Section
812.28

Acceptance of data from clinical investigations conducted outside the United States.

Section
812.30

FDA action on applications.

Section
812.35

Supplemental applications.

Section
812.36

Treatment use of an investigational device.

Section
812.38

Confidentiality of data and information.