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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health
FDA's unique device identification system is designed to adequately identify devices through distribution and use. Its requirements were designed to be phased in over seven years according to established compliance dates based primarily on device classification.
The compliance dates established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are:
- September 24, 2018, for the following requirements:
- Standard date formatting (21 CFR 801.18),
- Labeling (21 CFR 801.20, 21 CFR 801.50), and
- Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and
- September 24, 2020, for direct mark requirements (21 CFR 801.45).
This guidance describes FDA's intention with regard to enforcement of these requirements for class I and unclassified devices.
This guidance also describes FDA's direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory.
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" refer to the labeler, as defined in 21 CFR 801.3.
This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (section 701(h)(1)(C)(i) of the FD&C Act and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.
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-2017-D-6841.