With a compliance date of September 24, 2022, the US Food and Drug Administration (FDA) announced that it will delay implementation of its requirement to submit Unique Device Identification (UDI) data for hazardous consumer health products low. Consumer health products, as described in FDA guidelines, include Class 1 devices typically sold directly to consumers, such as digital health products and consumables. of FDA guidelines extends the data submission compliance date 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?
The UDI rules (21 CFR Parts 801 and 830) require all medical devices to carry a UDI on their labels and packaging, unless an exception or an alternative method of labeling applies. All UDIs must be issued by an FDA-accredited issuing agency. FDA regulations lay out very specific technical requirements for UDIs, which have significant implications for device manufacturers. To facilitate compliance, FDA has been phasing in UDI implementation over the past seven years.
In addition to the labeling requirement, the UDI rules require manufacturers to submit data about key device characteristics to the FDA’s Globally Unique Device Identifier (GUDID) database, which provides a repository of safety information that FDA monitors the distribution and use of the device (21 CFR § 830.300).
What demand is lagging for consumer health products?
FDA is delaying the GUDID filing requirement until December 8, 2022. However, FDA is not delaying other UDI labeling requirements, such as the basic requirement that every device label and packaging have a UDI, unless an exception or alternative labeling method applies.
What are consumer health products?
“Consumer health products” are Class 1, 510(k) exempt devices sold directly to consumers, over the counter or in brick-and-mortar or online stores, that are not:
Class 1 reserved equipment;
life support equipment; or
Devices distributed in professional health care facilities and intended for use by health care professionals only.
The new guidance provides additional insight into the types of devices the FDA does and does not consider for consumer health products. If labelers have questions about whether their products are considered consumer health products, questions can be sent to FDA at [email protected].
If I use a Universal Product Code (UPC), instead of a UDI, am I required to submit information to GUDID?
Yes. Regardless of whether a labeler attaches a UDI or a UPC, information about the device must be submitted to FDA via the GUDID. of new instruction extends the GUDID submission date to December 8, 2022.
A Class 1 device bearing a Universal Product Code (UPC) on its label and packaging is considered to meet the UDI labeling requirements. In other words, with lower risk (that is class 1) devices do not need to have a UDI, as long as the label and packaging of the device carry a UPC code. Consumer health products are typically already labeled with a UPC, so using a UPC to meet UDI labeling requirements provides significant efficiencies for manufacturers of Class 1 consumer health products.
Why did the FDA delay implementation?
The FDA explains that most consumer health products are typically labeled with a UPC, which identifies the products at a very granular level. FDA expects that the same device may undergo frequent UPC changes, and entering the required data into the GUDID may be burdensome for interested parties, given the frequency of changes.
Also, based on its review of postmarketing 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 the device’s safety throughout the product’s life cycle. 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