FDA Issues Draft Guidance to Clarify UDI Form, Content
Monday, July 25, 2016
There has been much uncertainty as the medical device industry shifts to FDA’s Unique Device Identification rule, and today the agency released draft guidance intended to clear the air regarding two aspects of the rule: the form and content of the Unique Device Identifier.
According to the original rule, which seeks to ensure every medical device has a unique identifier enabling it to be tracked from its manufacturer to its users, UDI information must be presented on device labels and packaging in both easily readable plain text and in a format that facilitates automatic identification and data capture (AIDC). The draft guidance put out today provided more detail as to what each of those formats should look like.