New FDA Draft Guidance Sheds Light On Regulation of 'Mobile Medical Apps' and Other Software


BNA Medical Devices Law & Industry Report Vol. 5, No. 16

By: Keith Barritt

FDA regulatory attorneys have appreciated for decades that software alone can be considered a "medical device.'' As early as 1989 the FDA issued a draft policy on the regulation of software. However, in 2005, recognizing that medical software had advanced by leaps and bounds since 1989 and would likely continue to evolve rapidly, the FDA took the rather unusual step of rescinding its 1989 draft policy, erasing it completely from the website, leaving industry somewhat in the dark as to when software would be considered a regulated device.

With the growing phenomenon of medical device applications for smartphones and other mobile platforms, in late July the FDA released a new draft guidance on the regulation of "mobile medical applications'' (5 MELR 476, 7/27/11). This document is a very welcome effort to bring clarity to the issue of when a mobile phone app is subject to FDA regulation as a "medical device.'' Public comments are due by October 19, 2011.