The FDA has finally published the long-awaited final rule on Unique Device Identification (UDI). I was in the audience at the UDI Conference this morning when Jay Crowley of the FDA made the announcement. Sparkling juice was distributed to the entire audience of 400+ attendees shortly after the announcement. See “FDA finalizes new system to identify medical devices“).
Yesterday Mr. Crowley arrived at the conference opening with a short beard. George Wright IV suggested that perhaps he wasn’t shaving until the final rule was published. Sure enough, he arrived this morning with the beard shaved off. He was due to start speaking at 8:30am but puttered around the podium computer for 15 minutes, apparently waiting for the notice to go live on the FDA site at exactly 8:45am.
The organization that held the current UDI conference has also announced plans to hold another UDI event–perhaps a workshop–in the “very near future”. I immediately signed RxTrace up to be a media partner for that event too.
Watch RxTrace for more on UDI and what the successful completion of this important final rule might mean for the future of pharma track & trace rules.