FDA guidance regarding consumer health products and the enforcement of Global Unique Device Identification Database submission requirements.

In its July 25, 2022, guidance document – The FDA (by and through the Center for Biologics Evaluation and Research and Center for Devices and Radiological Health) announced that it will not enforce Global Unique Device Identification Database (GUDID) submission requirements for class 1 devices “considered to be consumer health products that are required to bear a UDI on their labels and devices packages.” Likewise, the FDA does not intend to enforce GUDID submission requirements for Class 1 and unclassified device for a 75-day period. Notably excepted are “implantable, life-supporting, or life-sustaining devices”.

By way of background, on September 24, 2013, the FDA issued a final rule which established a UDI system which was demised to “adequately identify devices through the distribution and use (the “UDI Rule”). The UDI Rule promulgated device labeling requirements unless an exception applied as set forth in 21 CFR 801.20 and 21 CFR 801.50 (stand-along software regulated as a device). To wit, the UDI Rule required that devices be submitted to GUDID database to provide device health and safety information to patients, healthcare providers and consumers. The UDI Rule was set to be phased in from September 24, 2014, through September 24, 2002. FDA defined “consumer health products” as 510(K)-exempt class 1 devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores that do not fall within one or more of the categories…” Notably, the FDA also stated that Consumer health products are typically labeled with UPC codes: “which may serve as the UDI for class 1 devices.”

The FDA reiterated that certain class 1 devices not considered consumer health products “may pose greater risks to public health…” these devices will not be subject to the the GUDID submission requirements for 75 days. For instance, Class 1 Reserved Devices (a Class 1 devices that is intended for a use which is of substantial importance in preventing impairment of human health…or…that presents a potential unreasonable risk of illness or injury); Restricted Devices (restricted to sale, distribution or use only upon authorized prescription use); Implantable Devices; Life Supporting or Life Sustaining Devices & Certain Devices Distributed to Professional Healthcare Facilities and Intended for Use by Healthcare Professionals Only.

Source: https://www.regulations.gov/docket/FDA-2017-D-6841 (July 25, 2022)