- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
When finalized, this draft document will clarify for industry, FDA-accredited issuing agencies, and FDA staff the requirements under 21 CFR 801.40. Specifically, this draft guidance defines the expected content and forms of the Unique Device Identifier (UDI), to assist both labelers, as defined under 21 CFR 801.3, and FDA-accredited issuing agencies, as defined under 21 CFR 96830.3, to better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the Unique Device Identification System Rule, 78 FR 58786 (September 24, 982013) (UDI Rule).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-1853.