Procedures for 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 Device Establishments

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Section
807.20

Who must register and submit a device list?

Section
807.21

How to register establishments and list devices.

Section
807.22

Times for establishment registration and device listing.

Section
807.25

Information required for device establishment registration and device listing.

Section
807.26

Additional listing information.

Section
807.28

Updating device listing information.

Section
807.34

Summary of requirements for owners or operators granted a waiver from submitting required information electronically.

Section
807.35

Notification of registrant.

Section
807.37

Public availability of establishment registration and device listing information.

Section
807.39

Misbranding by reference to establishment registration or to registration number.