MD&M East

GUDID Submission Methods: Which One’s Right for You?

A few short months from now, manufacturers of Class III medical devices must comply with FDA’s unique device identification (UDI) rule. Part 1 of this series focused on the need for companies to start ...
JD Supra

FDA delays UDI database enforcement for low-risk devices

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a ...
RAPS

FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Later

The US Food and Drug Administration (FDA) has finalized a guidance document intended to outline the appropriate use of its Global Unique Device Identification Database (GUDID), an integral part of its ...
RAPS

FDA updates GUDID final guidance

The US Food and Drug Administration (FDA) issued an updated final guidance on Tuesday addressing the submission of unique device identifiers (UDIs) to the Global Medical Device Nomenclature Database ...
MD&M East

FDA Opens GUDID to the Public

FDA is building a medical device reference catalog through its Global Unique Device Identification Database, which it is opening to the public. Nancy Crotti FDA has opened the Global Unique Device ...