FDA Proposes Not Enforcing GUDID Requirements for Certain Class I Medical Devices

Oct. 26 2021

The US FDA is proposing to not require Class I devices that are exempt from 510(k) premarket notification requirements and are exclusively sold to consumers from the GUDID data submission requirements.

The US Food and Drug Administration (FDA) published a draft guidance document proposing updates to the Global Unique Device Identification Database (GUDID) submission requirements for certain Class I medical devices. The proposal states that the FDA does to not intend to enforce the GUDID data submission requirements for Class I medical devices that are 510(k) exempt and are exclusively sold to consumers. The FDA weighed the benefits and potential burdens of the requirements and found that the GUDID requirement would be burdensome to stakeholders since most of the applicable Class I devices utilize a Universal Product Code (UPC) as the Unique Device Identifier (UDI) and the UPCs change frequently. They also found that the GUDID information may be less important for Class I devices used by consumers after reviewing the safety and recall data. Therefore, given the potential burdens and benefits, the FDA has determined that they do not intended to enforce the GUDID submission requirements for these devices.

Note, the exception would not apply to Class I medical devices that must submit a 510(k) notification or are intended for use and sold to healthcare facilities.

Link to the Draft Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-unique-device-identification-policy-regarding-global-unique-device-identification

Comments may be submitted until December 13, 2021.

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