FDA Analysis of Global UDI Database Shows Increasing Submissions

The FDA has posted the latest analytics on its Global Unique Device Identification Database (GUDID), reporting a significant increase in the number of submissions as of Jan. 10.

The digital catalog stores critical device specifications such as manufacturer and production information, intended use, safety and handling requirements for all medical devices.

As of summer 2019, the database contained two million records, but now houses nearly four million, showing a marked increase from the approximately 3.5 million submissions in September 2022.

The U.S. is still the top GUDID labeler, with 6,078 labelers as of Jan. 10. China comes in second with 914 labelers, Germany third with 484 and Canada fourth with 312.

Monthly creation of new company accounts spiked in November 2022 to almost 250 from less than 100 per month in the prior three years, but then dipped to about 150 a month later.