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 ...
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 ...
Regulators with the US Food and Drug Administration (FDA) have released a second, substantially more complete guidance document indicating how its Global Unique Device Identification Database (GUDID), ...
One day before the U.S. Food and Drug Administration’s (FDA) deadline for medical device companies to submit Class III product data to the FDA’s Production Global UDI Database (GUDID), GHX announced ...
The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online.
The Food and Drug Administration has released guidance to manufacturers for submissions to its Global Unique Device Identification Database (GUDID). It deals with how to set up accounts and begin ...
The Food and Drug Administration recently released finalized guidance for medical device labelers for submitting data to the Global Unique Device Identification Database. A draft version of the ...
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 ...