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GUIDANCE DOCUMENT

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Immediately in Effect Guidance for Industry and Food and Drug Administration Staff November 2018

Final
Docket Number:
FDA-2017-D-6841
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA's unique device identification system is designed to adequately identify devices through 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) 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. 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.

For other device classes, the compliance dates established for direct mark requirements (21 CFR 801.45) are:

  • September 24, 2015, for LS/LS devices;
  • September 24, 2016, for class III devices; and
  • September 24, 2018, for class II 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 non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory. As described in further detail below, FDA does not intend to enforce the direct mark requirements under 21 CFR 801.45 for these devices when the device's unique device identifier (UDI) can be derived from other information directly marked on the device.

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.


Submit Comments

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-2017-D-6841.