General

  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
  7. General

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Section
814.1

Scope.

Section
814.2

Purpose.

Section
814.3

Definitions.

Section
814.9

Confidentiality of data and information in a premarket approval application (PMA) file.

Section
814.15

Research conducted outside the United States.

Section
814.17

Service of orders.

Section
814.19

Product development protocol (PDP).