Regulatory News

Class I Medical Device UDI Labeling and GUDID Submission Final

Jul. 28 2022

Summary
In the final guidance document, 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, the FDA states that they do not intend to enforce the GUDID submission requirements for class I, 510(k) exempt medical devices sold directly to consumers over-the-counter at brick-and-mortar and / or online stores (hereon referred to as “consumer health products”). The exemption does not apply to class I devices used in healthcare settings. 

The FDA also intends to extend the existing compliance policy regarding GUDID submissions for class I and unclassified medical devices, other than implanted, life-supporting, or life-sustaining (I/LS/LS) devices, regardless of whether they are consumer health products, for an additional 75 calendar days (before December 8, 2022). 

Date codes on class I and unclassified devices, other that I/LS/LS devices still need to adopt the new formatting by September 24, 2022.  

Background
The Unique Device Identification (UDI) rule requires medical devices to include a Unique Device Identifier (UDI) on its label and, in some cases, on the device itself, unless an exception applies. Manufacturers are also required to submit information about the device to the Global Unique Device Identification Database (GUDID), as appropriate. Additionally, when the UDI labeling requirements were published, the FDA established a standardized format for dates listed on medical devices. The UDI labeling and data submission requirements have slowly rolled out since September 2014, primarily based on the medical device class. 

Link to the Final Guidance Document 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: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices 

How Does this Impact You? Contact Us to Discuss 
If you have any questions on these final rules, please contact your customer service representative or email: info@us.bureauveritas.com
22B-066

Get in touchwith us
Would you like to receive marketing communication from Bureau Veritas?
Would you like to receive marketing communication from Bureau Veritas?