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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 807
    PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
  5. subpart B
    Subpart B—Procedures for Device Establishments

Subpart B. Subpart B—Procedures for Device Establishments

  • § 807.20 - Who must register and submit a device list?
  • § 807.21 - How to register establishments and list devices.
  • § 807.22 - Times for establishment registration and device listing.
  • § 807.25 - Information required for device establishment registration and device listing.
  • § 807.26 - Additional listing information.
  • § 807.28 - Updating device listing information.
  • § 807.34 - Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
  • § 807.35 - Notification of registrant.
  • § 807.37 - Public availability of establishment registration and device listing information.
  • § 807.39 - Misbranding by reference to establishment registration or to registration number.
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