FDA Unveils Final Details about Medical Device Tracking System
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), an integral part of the agency's pending oversight of the Unique Device Identification (UDI) system, works.
Background
Under FDA's UDI regulation, medical device manufacturers will soon have to start affixing device identifiers and production identifiers to most devices. While that information is somewhat useful on its own, its real potential will be unlocked when the information is tracked using the GUDID, which is set to act as a repository of information on the devices. For example, a doctor might scan a device code before using a device on a patient, allowing the doctor to see if the device has been recalled, how many devices are supposed to be in the package, whether the device has been discontinued, and to confirm that they have the right device in hand.
For more on GUDID, please see Focus' 10 June 2014 story, FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Later.
’Final’ Guidance
FDA first released a draft guidance document on GUDID in September 2013, and on 10 June 2014 released a "final" version of that guidance. But as it explained in its Federal Register announcement, "final" was something of a misnomer.
As explained by Regulatory Focus at the time, FDA indicated that the guidance was not yet complete, and at least 14 sections of the guidance would be finalized "separately."
"In order to provide labelers access to the latest information as soon as it is available, and address sections that received the most comments and questions, sections of this document are finalized; sections still in draft state are noted and will be finalized at a later time," FDA explained. "A future document" will address those now-empty sections, FDA confirmed in its Federal Register posting on the guidance.
As Focus explained at the time, FDA did make some changes to the draft guidance, such as adding substantial amounts of detail on the use of GUDID accounts and the classification of devices using the Global Medical Device Nomenclature (GMDN).
Final, Final Guidance
Now FDA is out with those "separate" additions to the guidance, Global Unique Device Identification Database (GUDID), and has released an updated and unified final guidance document on the GUDID system.
The detailed and extensive guidance, which weighs in at 42 pages in length, provides much of the technical "how-to" of the GUDID system, such as the role of each entity within the GUDID system, how to obtain a GUDID account, how to register a device and packages, and how to edit submissions.