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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
This document will assist industry, particularly labelers, as defined under 21 CFR 801.3, and FDA staff in understanding FDA’s requirements for direct marking of devices for unique device identification purposes. Under 21 CFR 801.45, "[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use." This guidance defines some terms used in the Agency’s regulations pertaining to the UDI direct marking requirements, including how FDA interprets the term "intended to be reprocessed" as used in 21 CFR 801.45. For additional background on the UDI system, see the Unique Device Identification System Final Rule, published on September 24, 2013 (78 FR 58786) (the UDI Rule - https://www.gpo.gov/fdsys/pkg/FR-2013-09-24/pdf/2013-23059.pdf ).
Throughout this guidance document, the terms "we," "us" and "our" refer to FDA staff from the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). "You" and "your" refers to the labeler, as that term is defined in 21 CFR 801.3.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
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-2015-D-2245.