FDA Takes GUDID Offline: Security breach? Or Proactive Measures?
FDA detected a "security vulnerability" earlier this month that spooked it enough to take the highly-touted Global Unique Device Identification Database (GUDID) offline until it was able to affix, ele [...]
FDA Applauds GUDID Progress, Eyes Class II Compliance Efforts
The Food and Drug Administration (FDA) reported that there have been over 240 user accounts set up in the agency’s Global Unique Identifier Database (“GUDID”) since the rule’s effectiveness date, and [...]
FDA’s UDI Initiative Continues to Roll Forward
Jeff Mazik, Vice President, Life Science Solutions, AssurX With the close of the 7th Annual UDI Conference in Baltimore late last month. The FDA took another big step forward in providing an electro [...]
FDA Moves UDI Initiative Further Down the Production Line
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. But it’s only fair to give equal space to something when they seem to get [...]
FDA Update on UDI Implementation for Registered Medical Device Establishments
In case you missed it, the FDA issued this update on UDI yesterday: Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III devices and devices [...]
Medical Device Industry Identifies Some Problems with Agency’s UDI Initiative
Let's start with what most everyone agrees on: The Unique Device Identification or UDI program is a swell idea. It gets a little trickier after that. In extensive comments, the Advanced Medical Techno [...]
