By David Lee Scher, MD
A draft proposal of the FDA guidelines for regulating mobile medical applications was released in July, 2011 . In response, the mHealth Regulatory Coalition sent detailed comments on the proposal . There was a recent piece in the Washington Times “The FDA’s Assault on Mobile Technologies” which, in my opinion, was misguided. No one in the healthcare industry (pharmaceutical, medical device, or technology) is enamored with the FDA. They recently drastically raised review fees for device companies and slow down approval processes more year after year. Between 2005 and 2008, the FDA clearance process time increased 30%, and has continually increased, notwithstanding increased funding and staffing levels. Regardless of its procedural faults, I will attempt to lay out my reasons why this regulatory body needs to oversee digital health technologies. This article should not be seen as a blanket endorsement of the FDA’s specific operational processes and policies, but as a rebuttal to the claim that it is assaulting the mobile health industry.