The UDI requirement for low-risk consumer health products has been delayed.

In the year As the September 24, 2022 compliance date approaches, the US Food and Drug Administration (FDA) has announced that it will delay enforcement of its requirement to provide Unique Device Identifier (UDI) information for low-risk consumer health products. As described in Consumer Health Products FDA guidance, include Class 1 devices typically sold directly to consumers, such as digital health products and consumer goods. of FDA guidance It extends the data submission date from September 24, 2022 to December 8, 2022, giving consumers more time to prepare their submissions to health product manufacturers.

What are the current UDI requirements?

UDI regulations (21 CFR parts 801 and 830) require all medical devices to contain UDI in their containers and packaging unless a special or alternative labeling method is implemented. All UDIs must be issued by an FDA-accredited issuing agency. FDA regulations set very specific technical requirements for UDIs, which have significant implications for device manufacturers. To facilitate compliance, the FDA has phased out UDI implementation over the past seven years.

In addition to the labeling requirement, the UDI regulations require manufacturers to submit information related to key device characteristics to the FDA’s Global Unique Device Identifier Database (GUIDID), which provides a repository of safety information that FDA tracks across all device distribution and use (21 CFR § 830.300).

What is the standard for consumer health products?

FDA is delaying the GUUDID submission until December 8, 2022. However, unless a unique or alternative labeling method is implemented, FDA will not delay other UDI labeling requirements as a basic requirement, such as labeling and packaging UDIs for each device.

What are consumer health products?

“Consumer Health Products” Section 1, 510(k) – Exempt devices are those sold directly to consumers in brick and mortar or online stores without a prescription. not at all:

• Class 1 Protected Equipment;

• Prohibited equipment;

• Implantable devices;

• Life support equipment; Or

• Devices distributed to professional healthcare facilities and intended for use by healthcare professionals only.

The new guidance provides more insight into the types of devices the FDA does and does not consider consumer health products. If labelers have questions about whether their products qualify as consumer health products, questions can be sent to FDA at [email protected].

If I use Universal Product Code (UPC) instead of UDI, should I enter information for GUDID?

yes. If the labeler attaches a UDI or UPC, information about the device must be submitted to FDA through the GUUDID. of New guidance Extends the GUIDID submission date to December 8, 2022.

Part 1 that contains the Universal Product Code (UPC) on the label and packaging is considered to meet the UDI labeling requirement. In other words, very low risk (That is Section 1) Devices must not contain a UDI as long as the device’s label and packaging contain the UPC code. Consumer health products are typically labeled with a UPC, so using a UPC to meet the UDI labeling requirement provides greater efficiency for manufacturers of Class 1 consumer health products.

Why did the FDA delay enforcement?

The FDA explains that most consumer health products are labeled with a UPC, which identifies products by granular level. FDA anticipates that the same device will make frequent UPC changes and that entering the required information into the GUDID may be difficult for stakeholders given the frequency of changes.

Also, based on its review of post-marketing data such as medical device reports and recall data for Part 1, FDA has developed a better understanding of the type of device that is useful for evaluating device safety throughout the product life cycle. This, the FDA explains, does not include information on low-risk consumer health products.