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# FDA Won’t Enforce ID Submission for Some Class 1 Devices
- URL: https://www.fdaweb.com/fda-wont-enforce-id-submission-for-some-class-1-devices/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150353

FDA has issued a draft guidance, *Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices*, to revise a section of a 7/1/20 guidance on compliance dates for Class 1 and unclassified devices. The [draft](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-unique-device-identification-policy-regarding-global-unique-device-identification?utm%5Fmedium=email&utm%5Fsource=govdelivery) says certain Class 1 devices are considered by the agency to be consumer health devices for which it does not intend to enforce Global Unique Device Identification Database (GUDID) submission requirements. The document also explains how a labeler of a Class 1 device can determine if their device is within the scope of the compliance policy.

“With respect to Class 1 devices that are considered consumer health products,” the draft says, “FDA believes that the entry of universal device identification (UDI) data into GUDID, especially given the frequent changes to the universal product codes serving as the UDIs for these devices, is burdensome to stakeholders.”

The draft says Class 1 devices that the agency does not consider to be consumer health products may pose greater risks to public health and thus are not covered by the compliance policy.