Last month, the FDA issued its guidance document Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices and a commentary by Bakul Patel. The essence of the form of interoperability addressed is the transfer […]
Hey, biomed! It’s me, Bob in IT. I’m from the networking team. I know we haven’t spoken much, but I think we should. You see, we’ve got some problems we need to solve. I have […]
A beta version of the government’s unique device identifier (UDI) database, called AccessGUDID, is available online. After some initial poking around, I have a few observations. A basic search function allows you to search by […]
In a January 2014 blog post, I reported on a third visit to the FDA’s own scorecard for its 2013 Action Plan. As of Jan. 1, 2015, this page showed a last updated date of […]
As I noted in a June blog on unique device identification (UDI), there was a proposal under consideration that would have required electronic health records (EHRs) to have the ability to capture UDIs–at least for […]
The use of unique device identification (UDI) labels for medical devices will soon begin, along with a global UDI database (dubbed GUDID) hosted by the U.S. Food and Drug Administration. Here, “soon” has a multiyear […]
In July 2013 and October 2013, I addressed the U.S. Food and Drug Administration’s progress in completing the various elements of improvements to its postmarket surveillance program. This effort has 14 parts divided among three […]
Back in July, I wrote about the first deadline that the U.S. Food and Drug Administration had set for itself with respect to a series of activities to improve its postmarket surveillance system. Of the […]
