FDA regulation

By Brian Dolan June 9, 2016
In 2012 The Wall Street Journal published a story that quoted a big medical device company spokesperson explaining that they couldn't provide patients the medical device data gathered by implanted devices inside their own bodies because regulators wouldn't allow it. "Medtronic says federal rules prohibit giving Ms. Hubbard's data to anyone but her doctor and hospital. 'Our customers are...
By Brian Dolan June 6, 2016
Next month the FDA is hosting a public advisory committee meeting to discuss a change to the intended use of Dexcom's G5 Mobile Continuous Glucose Monitoring System (CGM) device that would allow the company to market the G5 as a CGM patients can base treatment decisions on. Currently, Dexcom's CGMs are considered adjunctive devices, which means they carry an asterisk that notes they are intended...
By Brian Dolan November 24, 2015
Considering recent events, big name consumer brands are more likely than ever to move into regulated medical devices. Two weeks ago Apple CEO Tim Cook told a newspaper that while his company wouldn't put the Apple Watch through the motions of an FDA clearance process, Cook "wouldn't mind putting something adjacent to the watch through it." He said that before adding maybe that'd be an app or...
By MHN Staff August 5, 2015
By Bradley Merrill Thompson Healthcare in America needs disrupting. The media has widely reported on the high cost of, and poor outcomes produced by, the US health care system. Fortunately, attracted by possible profit in a market that currently constitutes over 17 percent of GDP, quite a few startups are anxious to do the needed disrupting. Indeed, innovators from many places outside of...
By MHN Staff April 13, 2015
By Bradley Merrill Thompson With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor...
By MHN Staff February 27, 2015
By Bradley Merrill Thompson Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile medical apps. Then, last month, in two separate draft guidances FDA explained the limits on its oversight of apps used for general wellness like fitness trackers, as well...
By Brian Dolan August 1, 2014
Kinsa's smartphone-connected thermometer The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. The agency made clear the deregulatory move would not necessarily exempt the device makers from other steps like appropriately registering and labeling their...
By Brian Dolan May 1, 2014
Vital Connect's HealthPatch This past month the FDA cleared two mobile medical apps and one digital health platform as 510(k) Class II medical devices. McKesson, one of the most vocal health IT companies lobbying for changes to how the FDA regulates medical software, secured clearance for a mobile medical app called McKesson Cardiology ECG Mobile. The web-based version of McKesson Cardiology...
By MHN Staff March 3, 2014
By Bradley Merrill Thompson This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to have this discussion, and then I’ll get into the recommendations that the so-called “FDASIA working group” made with regard to how to improve FDA regulation. Current...
By Brian Dolan May 22, 2013
This week the US Food and Drug Administration sent a letter to Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urinanalysis system, that instructs the company to seek 510(k) clearance of its mobile medical app or convince the FDA that such a clearance is not necessary. Sending an "it has come to our attention letter" like this is a rare action for the...