The FDA’s Center for Devices and Radiological Health (CDRH) has issued an update on the upcoming Unique Device Identifier (UDI) requirements.
Upcoming compliance dates for UDI requirements are:
- September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices
- September 24, 2016 for class II devices
Upcoming dates for Global Unique Device Identification Database (GUDID) Data Submission:
- January 2015, they will begin accepting GUDID account requests from labelers of I/LS/LS devices.
- Later in 2015, they plan to accept GUDID account requests from labelers of class II devices.
The CDRH has provided steps (Suggested steps are included on the UDI website) to help device labelers prepare to meet UDI requirements before actual data submission to GUDID. Following these steps will give labelers time to meet requirements and to work with the CDRH if they have problems coming into compliance. In January 2015, the CDRH will host a webinar to help Class II and I/LS/LS device labelers prepare to comply with the UDI rule.
The CDRH plans to address several UDI issues in 2015, such as: UDI direct marking requirements, convenience kits, posting of decisions on UDI exceptions and alternatives. They are working with the National Library of Medicine (NLM) to give the public search and download access to published records in the GUDID by the spring of 2015. The CDRH hopes to have the GUDID system implemented over several years. The CDRH’s “focus is getting the system implemented correctly and actively helping companies comply with system requirements.”
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