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2015 UDI Compliance Date Extended

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The FDA has recently issued a guidance document stating that it is extending the compliance date for Implantable, Life-Supporting and Life-Sustaining devices one month to October 24, 2015. This extension also applies to any labelers of Class III devices who previously received an extension to September 24 of this year.

This decision is due to the need to take the GUDID system offline temporarily while it develops and deploys a software patch to address some security issues. The FDA has stated previously that it does not anticipate full functionality to be restored until at least August 20. However, it has since restored the ability to submit records to the GUDID in SPL format.    

Please remember that, due to submissions in SPL format currently being accepted by the FDA, Reed Tech customers can continue to make submissions and move forward in their compliance programs, despite the current limited functionality of the GUDID. However, all affected device labelers may now take advantage of the extended compliance date, including Reed Tech customers.

As always, Reed Tech UDI experts are available to answer any questions you have on this topic.



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Comments

  • Vasumathi Ram

    Great resources!
    I have the following questions:
    1. Is there a mandate on providing UDIs in claim forms (837s) used by health plans
    2.How does the 837 file accept a UDI
    3. When a UDI is submitted, should a qualifier indicating the issuing agency also be prefixed to the UDI ?