With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that it will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer health products. Consumer health products, as described in the FDA guidance, include class 1 devices that are typically sold directly to consumers, such as digital health products and consumables. The FDA guidance extends the compliance date for data submission from September 24, 2022 to December 8, 2022, giving manufacturers of consumer health products more time to prepare their submissions.
What are the Current UDI Requirements?
The UDI rules (21 C.F.R. Parts 801 & 830) require all medical devices to bear a UDI on their labels and packaging, unless an exception or an alternative labeling method applies. All UDIs must be issued by a FDA-accredited issuing agency. FDA regulations set forth very specific technical requirements for UDIs, which carry significant implications for device manufacturers. In order to facilitate compliance, FDA has phased in UDI implementation over the past seven years.
In addition to the labeling requirement, the UDI rules require that manufacturers submit data relating to key device characteristics to FDA's Global Unique Device Identification Database (the GUDID), which provides a repository of safety information that FDA monitors throughout a device's distribution and use (21 C.F.R. § 830.300).
What Requirement is Being Delayed for Consumer Health Products?
FDA is delaying the GUDID submission requirement until December 8, 2022. However, FDA is not delaying other UDI labeling requirements, such as the baseline requirement that each device label and packaging bear a UDI, unless an exception or an alternative labeling method applies.
What are Consumer Health Products?
"Consumer health products" are class 1, 510(k)-exempt devices that are sold directly to consumers, over-the-counter in either brick-and-mortar or online stores, that are not:
- Class 1 reserved devices;
- Restricted devices;
- Implantable devices;
- Life-supporting devices; or
- Devices distributed to professional healthcare facilities and intended for use by healthcare professionals only.
The new guidance provides additional insight into the types of devices FDA does and does not consider consumer health products. If labelers have questions on whether their products are considered consumer health products, inquiries may be sent to FDA at GUDIDSupport@fda.hhs.gov.
If I use a Universal Product Code (UPC), Instead of a UDI, Am I Required to Submit Information to the GUDID?
Yes. Whether a labeler attaches a UDI or a UPC, information about the device must be submitted to FDA through the GUDID. The new guidance extends the GUDID submission date to December 8, 2022.
A class 1 device that bears a Universal Product Code (UPC) on its label and packaging is deemed to meet the UDI labeling requirement. In other words, most low-risk (i.e., class 1) devices do not have to bear a UDI, so long as the device label and packaging bear a UPC code. Consumer health products are typically already labeled with a UPC, so utilizing a UPC to satisfy the UDI labeling requirement offers significant efficiencies to manufacturers of class 1 consumer health products.
Why Did FDA Delay Enforcement?
FDA explains that most consumer health products are typically labeled with a UPC, which identifies products at a very granular level. FDA expects that the same device may undergo frequent UPC changes and entry of required data into the GUDID may be burdensome to stakeholders, given the frequency of changes.
Also, based on its review of post-market information for class I devices, such as medical device reports and recall data, FDA has developed a better understanding of the type of device data that is particularly useful in evaluating device safety throughout a product lifecycle, which, FDA explains, does not include data on low-risk consumer health products.
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