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Post-Market Surveillance: UDI Compliance for Class I Devices Moves Forward with New Deadline

 

The FDA established the unique device identification (UDI) system to identify medical devices sold in the United States from manufacturing through patient use, which would ultimately modernize post-market surveillance.  The final UDI Rule was published on September 24, 2013, with Class I and unclassified devices being the last implementation phase.  

In 2020 the FDA adjusted enforcement deadlines for some UDI requirements of Class I and unclassified devices, including UDI labeling, date formatting and Global Unique Device Identification Database (GUDID) submission requirements.  

This month, the FDA posted 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. 

Class I and unclassified devices will now have to comply with UDI by September 24, 2022. However, the FDA will not enforce GUDID submissions—except for implantable, life sustaining or life supporting devices—until December 8th, 2022.   

Here’s what we know.  

What Is the UDI Rule?  

The FDA’s drive behind the UDI regulation is to identify devices through distribution and use. UDI is a distinct alphanumeric/numeric code that will provide a single, globally harmonized system for traceability of a medical device.  

The UDI Rule requires device labels and packages, with some exceptions, to include a UDI. Devices that are required to have these labels must also be submitted to the repository of device safety information, GUDID, which is accessible to the public. This gives patients and healthcare providers visibility into medical device safety information.  

Extensions were granted to the original deadline to reduce the burden associated with the UDI Rule for finished devices.  

The Intention Behind UDI Compliance  

The UDI system will allow healthcare professionals to reduce medical records by quickly identifying devices and specific attributes related to their safe use. UDI will provide a standardized system for distributors, manufacturers and healthcare providers to manage recalls.  

It will also result in better reporting and a more effective method of analyzing adverse events and will help organizations identify counterfeiting, to provide a more secure, global supply chain.  

UDI’s effectiveness depends on high-quality data integrated into data sources such as the supply chain and electronic health records. This means UDI data must be accurate and complete.  

Enhancing Patient Safety and Efficiency in the Supply Chain 

The UDI system will enable healthcare providers to get the exact information needed to report adverse events accurately and manage recalls.   

The result is traceability throughout the supply chain for quicker recall and adverse event resolution and, ultimately, greater patient safety and higher efficiencies in the global supply chain.  

Healthcare professionals should be prepared to comply with the UDI Rule once it takes effect on September 24th. Not sure where to start? Get in touch with us to learn more.  

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