On September 24, 2013, FDA published a final rule establishing a UDI system designed to adequately identify devices through distribution and use (the “UDI Rule”). Implementation of the UDI-related regulatory requirements set forth in FDA’s 2013 rule was based on a phased series of established compliance dates based primarily on device classification, which ranged from September 24, 2014, to September 24, 2020. However, the compliance deadlines for manufacturers of most class I devices have been pushed back several times due to the COVID-19 pandemic and other concerns, including policy and technical issues.
On July 25, FDA issued the final guidance, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices,” which provides an extension for GUDID submission of UDI information for class I devices or provides enforcement discretion for submission of information to the GUDID for certain categories of class I devices. The guidance further provides relief for direct marking other devices which were manufactured prior to applicable compliance dates and may still remain in inventory.
For class I devices, the guidance says FDA will not enforce its requirement that manufacturers of such low-risk medical devices submit their products to the GUDID until December 8. This represents a 75-day delay from the date set in the July 2020 version of the guidance. However, FDA will maintain its enforcement date for compliance with UDI labeling, date format, and direct-mark requirements for Class I and unclassified devices on September 24, 2022 as previously planned (which already reflected previous extensions from the dates set forth in the final UDI rule).
In addition, this new guidance provides relief from GUDID submission compliance for class I devices termed as “consumer health products”: As defined in this guidance, such products are those class I devices which are 510(k)-exempt devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores, and are not otherwise considered reserved, restricted, implantable or life-saving/life-supporting devices. For products meeting this definition, FDA does not intend to enforce the GUDID submission requirements.
The guidance also allows for finished devices held in inventory prior to their applicable UDI compliance dates to forego direct marking requirements provided that the UDI information can be derived through other information. Under 21 CFR § 801.30(a)(1), finished devices which were manufactured and labeled prior to their applicable UDI compliance date relative to the device classification have a safe harbor for 3 years prior to being subject to the full scope of applicable UDI requirements. In the new guidance, FDA foregoes compliance with direct marking of any such devices still held in inventory which would otherwise be subject to the direct marking requirements under 21 CFR 801.45 provided that the UDI information can be derived from other information marked on the device. Any such devices stored in inventory will still require UDI information on the labels, formatting of dates on the labels according to the standardized format, and submission of UDI information to the GUDID three years past the applicable compliance date, which has already expired for all class II and class III devices.
Authored by Lina Kontos and Randy Prebula