U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) Draft Guidance for Industry and Food and Drug Administration Staff July 2016

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2016-D-1853
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

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 Specifically, this draft guidance defines the expected content and forms of the Unique Device Identifier (UDI), to assist both labelers, as defined under 21 CFR 801.3, and FDA-accredited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).

Submit Comments

Submit Comments Online

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:

Dockets Management
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.