FDA Finishes Guidance on Medical Device UDI Database
The Food and Drug Administration finalized the remaining parts of a new guidance on the agency’s database for medical device “unique device identifiers” (UDIs). The guidance includes information for device labelers (in most instances, the device manufacturer) on how to…
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
use the Global Unique Device Identifier Database (GUDID), including how to establish GUDID accounts and begin initial submissions. It also contains examples of medical device labels that include UDIs. Labelers are required to submit data to GUDID if a device must be labeled with a UDI, FDA said in its UDI final rule. The agency had issued part of the guidance in early June (see 14061028). Comments on the guidance may be submitted at any time, said FDA in a concurrent Federal Register notice (here).