Postponement of UDI requirement for low-risk consumer health products
As the September 24, 2022 compliance date approaches, the U.S. Food and Drug Administration (FDA) has announced that it will delay enforcing its requirement to submit Unique Device Identification (UDI) data for low-risk consumer health products. Consumer health products, as described in the FDA Guidelines, include Class 1 devices that are typically sold directly to consumers, such as digital health products and consumables. The FDA Guidelines extends the compliance date for data submission from September 24, 2022 to December 8, 2022, giving consumer health product manufacturers more time to prepare their submissions.
What are the current UDI requirements?
UDI rules (21 CFR Parts 801 & 830) require all medical devices to carry a UDI on their labels and packaging, unless an exception or alternative labeling method applies. All UDIs must be issued by an FDA-accredited issuing agency. FDA regulations establish very specific technical requirements for UDIs, which have significant implications for device manufacturers. To facilitate compliance, the FDA has been gradually implementing UDI over the past seven years.
In addition to the labeling requirement, UDI rules require manufacturers to submit key device characteristic data to the FDA’s unique Global Device Identification Database (GUDID), which provides a repository safety information that the FDA monitors throughout the distribution and use of a device (21 CFR § 830.300).
What requirement is delayed for consumer health products?
The FDA is delaying the GUDID submission requirement until December 8, 2022. However, the FDA is not delaying other UDI labeling requirements, such as the basic requirement that every device label and package carry a UDI, unless an exception or alternative labeling method applies.
What are consumer health products?
“Consumer healthcare products” are Class 1, 510(k)-exempt devices that are sold directly to consumers, over-the-counter in physical or online stores, that are not:
Class 1 reserved devices;
Vital devices; Where
Devices distributed to professional healthcare facilities and intended for use by healthcare professionals only.
The new guidelines provide additional information on the types of devices the FDA considers and does not consider consumer health products. If labelers have questions about whether their products qualify as consumer health products, inquiries can be sent to the FDA at [email protected].
If I use a Universal Product Code (UPC), instead of a UDI, do I have to submit information to the GUDID?
Yes. Whether a labeler attaches a UDI or UPC, the device information must be submitted to the FDA via the GUDID. The new direction 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 people at low risk (that’s to say, Class 1) devices do not have to carry a UDI, as long as the device label and packaging carry a UPC code. Consumer health products are usually already labeled with a UPC, so using a UPC to satisfy the UDI labeling requirement offers significant efficiencies for Class 1 consumer health product manufacturers. .
Why did the FDA delay the application?
The FDA explains that most consumer health products are typically labeled with a UPC, which identifies the products at a very granular level. The FDA expects that the same device may undergo frequent UPC changes and entering the required data into the GUDID can be cumbersome for stakeholders given the frequency of changes.
Additionally, based on its review of postmarket information for Class I devices, such as medical device reports and recall data, the FDA has developed a better understanding of the type of device data that is particularly useful for evaluating device safety throughout the product lifecycle, which the FDA explains does not include data on low-risk consumer health products.
Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XII, Number 220