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GUDID Opens for I/LS/LS Device Labelers in January

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Today, the FDA released a number of updates to the final rule on Unique Device Identifiers for medical devices.

GUDID Account Requests for Implantable, Life-Sustaining, or Life-Supporting (I/LS/LS) Devices will be available January 26, 2015. FDA will allow Class II manufacturers to begin the process of establishing a GUDID Account later in 2015, though an exact date has not yet been released.  Manufacturers of Class III devices with active GUDID Accounts may continue to submit lower classes of device data to the GUDID.

In the update to industry, FDA urges device manufacturers to begin the process of collecting, organizing, and validating GUDID data prior to beginning the GUDID Account Set Up process. The agency notes that experience and feedback from industry has shown that taking these steps to prepare data prior to beginning the GUDID Account Setup process may ensure readiness to comply and streamline the submission process.

Additionally, updates have been made to the HL7 SPL Implementation Spec and GUDID Data Elements Table. These updates include changes to field length requirements for some data attributes, such as model or version number.

Finally, FDA notes the search and download feature of the GUDID will be available to the public in Spring 2015.

For more information on how these updates may affect UDI implementation, please contact me at +1-215-441-6538 or hlentz@reedtech.com.