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  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

Part 814. PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES

  • SUBPART A [§ 814.1 - § 814.19] - Subpart A—General
  • SUBPART B [§ 814.20 - § 814.39] - Subpart B—Premarket Approval Application (PMA)
  • SUBPART C [§ 814.40 - § 814.47] - Subpart C—FDA Action on a PMA
  • SUBPART D - Subpart D—Administrative Review [Reserved]
  • SUBPART E [§ 814.80 - § 814.84] - Subpart E—Postapproval Requirements
  • SUBPART F - Subparts F-G [Reserved]
  • SUBPART H [§ 814.100 - § 814.126] -
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