Biosense Modifies Urinalysis App To Comply With FDA
This article was originally published in The Gray Sheet
Executive Summary
The app developer unveiled its plans to comply with FDA regulations for its uChek urinalysis app, including the submission of a 510(k) for the full-feature product and launch of a Lite version. FDA sent a letter to Biosense questioning its earlier launch of the app without a 510(k) after an article ran in “The Gray Sheet” assessing its regulatory status.
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Editor’s Picks: Notable Gray Sheet Stories From 2013
2013 was a challenging year on some fronts for industry, and the impasses in Congress did not help. But there were some positive policy signals from FDA. There were also some very significant rules finalized – for the unique device identification and the Physician Payment Sunshine Act programs – that signal the need for important implementation efforts in 2014. Here are some of last year’s most important stories from “The Gray Sheet,” based on web hits and editor prerogative.