May 2018 GUDID Release - 3 Necessary and Immediate Action Steps

Stefanie Wichansky

Stefanie Wichansky About The Author

Apr 25, 2018 12:30:00 PM

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In May 2018, the FDA is planning to launch GUDID Release 2.3, and medical device leaders should be paying close attention. GUDID, or the Global Unique Device Identification Database, represents an FDA-administered database which serves as a reference catalog for every device with a unique device identifier (UDI). The information contained in GUDID is available to the public through the FDA's portal known as AccessGUDID. As part of the upcoming new release, key enhancements are being enacted, and consequently, the FDA has announced recommended action steps to be taken by medical device registrants.  

The major change coming out of the new GUDID release is the FDA's decision to publicly release the Premarket Submission Number and Supplement Number for each device.   The FDA has noted that premarket numbers provide an essential link to information about device safety and effectiveness, and making such information public is crucial to achieving the public health benefits of UDI.   To prepare for this change, the FDA is urging medical device companies to complete various action steps immediately, including the following:

Click HERE for Overview of Critical Medical Device Standards

1) Understand the FDA's plan to assess "releasability" of a Premarket Submission Number and Supplement Number, which can be found on the FDA's website.  The FDA has noted that it will be sensitive to confidentiality in making this determination, and therefore it will utilize the confidentiality information provided in the GUDID Device Registration and Listing Module (DRLM).

2) Ensure all your listings in GUDID contain all relevant listing numbers.

3) Thoroughly review, and update as necessary, the confidentiality designations you have assigned to the proprietary names in all your device listing records within the DRLM. Changes to these designations can be made by revising the Proprietary Brand Name Confidentiality Flag in the DRLM or by contacting the Device Registration and Listing Office at reglist@cdrh.fda.gov.

If you have already addressed these steps, congratulations and get ready for the review period described in the following paragraph. If you have not yet addressed these items, heed the FDA's advice and get on it now.  

Fortunately, the FDA plans to allow medical device companies the opportunity to review which premarket submission and supplement numbers will be made public prior to the actual release of such information. The review period will commence in May 2018, and companies will be permitted to review the information and make necessary changes within the DRLM at this time. Be sure to conduct your review in a timely manner since the FDA will begin releasing the information publicly in June 2018.

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