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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
  7. Subpart B—Procedures for Device Establishments

21 CFR Part 807 - Subpart B - Procedures for Device Establishments

  • CFR
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  1. § 807.20 Who must register and submit a device list?
  2. § 807.21 How to register establishments and list devices.
  3. § 807.22 Times for establishment registration and device listing.
  4. § 807.25 Information required for device establishment registration and device listing.
  5. § 807.26 Additional listing information.
  6. § 807.28 Updating device listing information.
  7. § 807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
  8. § 807.35 Notification of registrant.
  9. § 807.37 Public availability of establishment registration and device listing information.
  10. § 807.39 Misbranding by reference to establishment registration or to registration number.

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