FDA Guidance on UDI Compliance Requirement for Low-Risk Devices.

On July 22, 2022 FDA has posted a guidance on UDI I.e Unique Device Identification system. This particular guidance explains the FDA’s compliance policy regarding Global Unique Identification Database submission requirement (GUDID) for Class I devices which are considered consumer health products. FDA defines consumer health products as “510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores”. 

According to this guidance the devices which are qualifying as consumer health products are exempted from GUDID submissions requirement however these devices should bare UDI data on their labelling and packaging. 

The Class I devices which are not as per agency’s the definition of consumer health product not exempted from GUDID submission requirement these devices granted compliance deadline extension, to DEC 8,2022. The affected device types are  

• Class I reserved devices, which need %10(k) clearance. 
• Implantable devices which are remain implantable no less than 30 days. 
• Life sustaining devices. 
• Restricted devices. 

The life sustaining devices do not qualify for December 2022 GUDID compliance deadline extension. The unclassified devices which require FDA 510(k) premarket notification from US regulators do not apply GUDID submission extension. 

In 2013 FDA published final rule for UDI, after 5 years agency released a draft guidance for Class I and unclassified devices.  FDA then gone ahead with plans to exempt Class I devices that are consumer health products from the GUDID submission requirements. This reflects the burden of GUDID submission on medical device manufacturers as they need to carry barcode means UPC, universal product code for scanning at the point of sale. Previously the FDA planned to enforce the requirement on Class I and unclassified devices starting Sept. 24 but now the deadline is extended. 

Agency believes that this brief extension of the policy can help facilitate submission of high-quality UDI data to GUDID. 

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