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Two new sections were added to FDA’s 21 CFR (Code of Federal Regulations) with the release of the Unique Device Identification (UDI) rule in September 2013. Subpart B, Labeling Requirements for Unique Device Identification, was added to 21 CFR 801; and 21 CFR Part 830, Unique Device Identification, was created.
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 Additionally, several sections of 21 CFR were modified to remain consistent with the new UDI rule. An overview of the affected sections can be found in the table below and a detailed description of the revisions can be found in the FDA’s UDI guidance document.

21 CFR Sections Modified by UDI Rule

Part 803 – Medical Device Reporting
Part 806 – Medical Devices: Reports of Corrections and Removals
Part 810 – Medical Device Recall Authority
Part 814 – Premarket Approval of Medical Devices
Part 820 – Quality System Regulation
Part 821 – Medical Device Tracking Requirements
Part 822 – Postmarket Surveillance


In response to these updates, medical device manufacturers should perform a gap assessment of their Quality Management System (QMS) to determine what, if any, procedures, instructions, and forms need to be revised for UDI compliance. Manufacturers should also assess the timing to implement QMS updates to align with the UDI compliance dates applicable to their product(s).

This gap assessment should be included as part of a UDI implementation quality plan, which you can learn more about in the second UDI series article.

If you need assistance performing a QMS gap assessment for UDI conformance, please call 512-328-9404 or contact us at