Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI. “But UDI is not over,” says Ardi Batmanghelidj, President and CEO of Innovatum, a software and regulatory consulting company specializing in life science labeling and […]
5 Unique Device Identification Challenges Read More »
Let’s face it, there are still those amongst us who grumble at the mention of having to comply with the UDI regulations. To them, it’s simply a matter of having to comply to stay in business. There are those of us however, who are advocates of the regulation and appreciate the benefits of UDI. We
Real Benefits of UDI in the Operating Room and Beyond Read More »
Pulling information out of the FDA GUDID is simple. The public can access information contained in the GUDID through AccessGUDID. The FDA, in partnership with the National Library of Medicine (NLM) has announced that through AccessGUDID, anyone can search or download information that device labelers have submitted to the GUDID about their medical devices. GUDID
Comparing GUDID Submission Options Read More »