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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER H—MEDICAL DEVICES
  6. PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

21 CFR Part 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

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  1. Subpart A—General Provisions (§ 807.3)
  2. Subpart B—Procedures for Device Establishments (§§ 807.20 - 807.39)
  3. Subpart C—Procedures for Foreign Device Establishments (§§ 807.40 - 807.41)
  4. Subpart D—Exemptions (§ 807.65)
  5. Subpart E—Premarket Notification Procedures (§§ 807.81 - 807.100)
Authority:
21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360e-4, 360i, 360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.
Source:
42 FR 42526, Aug. 23, 1977, unless otherwise noted.

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