FDA’s unique device identification system is designed to adequately identify devices though distribution and use. The unique device identification system requirements are being 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) devices2 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. As described in further detail below, FDA does not intend to enforce standard date formatting, labeling, and GUDID data submission requirements under 21 CFR 801.18, 21 CFR 801.20, 21 CFR 801.50, and 21 CFR 830.300 for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements under 21 CFR 801.45 for these devices before September 24, 2022. The policy described in this guidance does not apply to I/LS/LS devices. This policy also does not apply to class I devices that FDA has by regulation exempted from the good manufacturing practice requirements because such devices are excepted from UDI requirements (see 21 CFR 801.30(a)(2)).
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. Although this guidance is immediately in effect, FDA will consider all comments received and revise the guidance document as appropriate.