Procedures for Foreign Device Establishments

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
  7. Procedures for Foreign Device Establishments

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Section
807.40

Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.

Section
807.41

Identification of importers and persons who import or offer for import.