An Overview of FDA’s Updated UDI Requirements for Class 1 Medical Devices

In July 2022, the U.S. Food and Drug Administration (FDA) updated its guidance on Unique Device Identifier (UDI) requirements. The guidance now includes Global Unique Device Identification Database (GUDID) submission requirements for certain Class 1 devices FDA considers consumer health products. FDA does not intend to enforce GUDID submission requirements for these devices when their labels are required to bear a UDI. 

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What Did the UDI Rule Establish? 

In September 2013, FDA published a final rule establishing the UDI system to “adequately identify devices through distribution and use.”  The rule set forth compliance dates ranging from September 24, 2014 to September 24, 2020, based on device classification.  

The UDI rule established requirements that:   

  • A device must bear a UDI on its label and packages unless an exception or alternative applies   
  • Special labeling must be implemented for stand-alone software regulated as a device  
  • Data about key characteristics of each device required to bear a UDI must be submitted to GUDID, FDA’s repository of device safety information  
  • Certain dates on device labels be in a standard format  

Class 1 Devices Considered Consumer Health Products  

Class 1 devices generally pose the lowest risk to users and many are over-the-counter products sold directly to consumers and exempt from 510(k) premarket notification requirements. FDA considers some of these devices to be “consumer health products”. 

Medical devices typically bear a Universal Product Code (UPC) 13. UPCs identify products very specifically and the UPCs on Class 1 consumer health products can change based on various factors, such as the product’s placement in a store or whether it has different packaging at different times.  

Because companies must enter UDI data into GUDID and because Class 1 consumer health products contain UPCs that undergo frequent changes, FDA has determined that the UDI requirement for these devices is “burdensome to stakeholders.” FDA also determined, through information such as medical device reports and recall data, that GUDID information is crucial for evaluating safety and making improvements for certain devices while being less important for others.   

Because of these findings, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for consumer health products.  

Class 1 Devices Not Considered Consumer Health Products  

Class 1 devices not considered consumer health products, such as those used in healthcare settings, are often subject to additional controls, including 510(k) requirements. These devices may pose a greater risk to public health. FDA has determined that these devices will remain subject to submission of UDI data into GUDID, as the data is important in safety evaluation and improvement efforts as well as the reduction of medical errors. UDI data for these devices may also help stakeholders integrate device use information into data systems. 

FDA does not intend to enforce the requirements for any Class 1 and unclassified device before December 8, 2022, with the exception of implantable, life-supporting, or life-sustaining (I/LS/LS) devices.  

Device manufacturers should be aware of whether FDA considers their device a consumer health product to be prepared for forthcoming enforcement of UDI regulations that apply to their product.  

Get assistance with FDA compliance.

Registrar Corp helps companies comply with FDA regulations, including UDI and GUDID requirements.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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