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U.S. Code Regulations Constitution Journal Apps
  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i7
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 814
    PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
  5. subpart A
    Subpart A—General

Subpart A. Subpart A—General

  • § 814.1 - Scope.
  • § 814.2 - Purpose.
  • § 814.3 - Definitions.
  • § 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.
  • § 814.15 - Research conducted outside the United States.
  • § 814.17 - Service of orders.
  • § 814.19 - Product development protocol (PDP).
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