Relabeling of a device that is required to bear a unique device identifier.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Unique Device Identification
  7. Requirements for a Unique Device Identifier
  8. Relabeling of a device that is required to bear a unique device identifier.

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§ 830.60 Relabeling of a device that is required to bear a unique device identifier.

If you relabel a device that is required to bear a unique device identifier (UDI), you must:

(a) Assign a new device identifier to the device, and

(b) Keep a record showing the relationship of the prior device identifier to your new device identifier.

[78 FR 58825, Sept. 24, 2013]


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