(c) In the event that a version or model of a device is discontinued, its device identifier may not be reassigned to another device. If a discontinued version or model is re-introduced and no changes have been made that would require the use of a new device identifier, the device identifier that was previously in use may be used to identify the device.
(d) In the event that an issuing agency relinquishes or does not renew its accreditation, you may continue to use a previously issued UDI until such time as
(a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.
(b) Whenever you create a new device package, you must assign a new device identifier to the new device package.
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.
Subpart D--FDA as an
830.200 When FDA will act as an issuing agency.
830.210 Eligibility for use of
830.220 Termination of
Subpart E--Global Unique Device Identification Database
830.300 Devices subject to device identification data submission requirements.
830.310 Information required for unique device identification.
830.320 Submission of unique device identification information.
830.330 Times for submission of unique device identification information.
830.340 Voluntary submission of ancillary device identification information.
830.350 Correction of information submitted to the Global Unique Device Identification Database.
830.360 Records to be maintained by the labeler.
Subpart D--FDA as an
(a) During any period where there is no accredited issuing agency,
(b) If FDA determines that a significant number of small businesses would be substantially and adversely affected by the fees required by all accredited issuing agencies,
When FDA acts as an issuing agency, any labeler will be permitted to use
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