UDI requirement for low-risk consumer health products delayed

With the September 24, 2022 compliance date approaching, the U.S. Food and Drug Administration (FDA) announced that it will be deferring enforcement of its requirement to submit UDI (Unique Device Identifier) ​​data for low-risk consumer healthcare products. Consumer healthcare products, as described in FDA guidelines, include Class 1 devices that are typically sold directly to consumers, such as B. digital health products and consumables. FDA guidance extends the compliance date for data submission from September 24, 2022 to December 8, 2022, giving manufacturers of consumer healthcare products more time to prepare their submissions.

What are the current UDI requirements?

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 alternative method of marking applies. All UDIs must be issued by an FDA-accredited issuing agency. FDA regulations set very specific technical requirements for UDIs that have a significant impact on device manufacturers. To facilitate compliance, the FDA has phased in UDI implementation over the past seven years.

In addition to mandatory labeling, UDI rules require manufacturers to submit data on key product characteristics to the FDA’s Global Unique Device Identification Database (GUDID), which is a collection of safety information that FDA monitors throughout a product’s distribution and use ( 21 CFR §830.300).

What requirement is delayed for consumer health products?

The FDA is deferring the GUDID submission requirement until December 8, 2022. However, the FDA is not delaying other UDI labeling requirements, such as: B. The basic requirement that every device label and packaging must bear a UDI, unless an exception or an alternative method of identification applies.

What are consumer health products?

“Consumer healthcare products” are Class 1 510(k)-exempt devices that are sold directly to consumers, ie, over the counter in brick-and-mortar or online stores Not:

  • Class 1 Reserved Devices;

  • Restricted Devices;

  • implantable devices;

  • life support 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 that the FDA uses and doesn’t consider for 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 need to submit information to the GUDID?

Yes. Regardless of whether a labeler affixes a UDI or a UPC, information about the product must be submitted to the FDA via the GUDID. The new guidelines extend the GUDID submission date to December 8, 2022.

A Class 1 device that bears a Universal Product Code (UPC) on its label and packaging meets UDI marking requirements. In other words, most low-risk (ie Class 1) devices do not need to carry a UDI as long as the device label and packaging carry a UPC code. Consumer healthcare products are typically already labeled with a UPC, so using a UPC to meet UDI labeling requirements offers Class 1 consumer healthcare product manufacturers significant efficiencies.

Why did the FDA delay enforcement?

The FDA explains that most consumer health products are typically labeled with a UPC, which identifies products at a very granular level. The FDA understands that the same product may undergo frequent UPC changes, and entering required data into the GUDID can be tedious for stakeholders given the frequency of changes.

In addition, based on its review of post-market information for Class I devices such as which the FDA states has no data on low-risk consumer health products.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XII, Number 220

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