January 20, 2015
Bradley Merrill Thompson
At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an "accessory" device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall...
March 6, 2013
Source: mHealth Regulatory Coalition FDA Report
Last week six members of the US House of Representatives Committee on Energy and Commerce wrote a letter to FDA Commissioner Margaret Hamburg MD to ask her when the agency expects to publish its final guidelines for how and when it regulates mobile medical apps as medical devices. The FDA draft guidance document on mobile medical apps was published...
February 18, 2013
Perhaps more than any other metric, the time it takes to secure clearance is the one that gets the most attention for 510(k) devices. An updated analysis from medical device quality assurance and regulatory consultants, The Emergo Group, finds that the average time it took for a medical device to complete the 510(k) process was about 138 days in 2011, down from 146 days in 2010. The company...