Feb 19, 2018
EMERGO SUMMARY OF KEY POINTS:
The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device manufacturers.
According to the agency’s announcement, an initial round of GUDID updates will go into effect in late March 2018, followed by additional enhancements in late summer 2018.
FDA’s first round of GUDID updates for 2018 include two key components:
Later this year, FDA will release premarket submission and supplement numbers into GUDID. (The agency notified stakeholders in January 2018 of this move.) Companies should make sure that their GUDID records include all necessary listing numbers, and that they have designated any proprietary information related to their devices as confidential in their GUDID records. The confidentiality issue is important because FDA continues to weigh whether to make premarket submission and supplement numbers publicly accessible.
Medical device market regulators in the US have launched a new website to provide public access to their Global Unique Device Identification Database (GUDID) designed to store device labelers’ information about their products.
New guidance from the US Food and Drug Administration lays out key components of Unique Device Identifier (UDI) form and content that medical device manufacturers should incorporate into their compliance efforts.