Congressional Leader, FDA Battle over mHealth Regulations
The US Food and Drug Administration (FDA) and members of a House subcommittee are currently examining the federal regulation of mobile medical apps. The director of the FDA’s Center for Devices and Radiological Health, Dr. Jeffrey Shuren testified that regardless of the platform, any application of medicine based on risk and function should be regarded and regulated as such.
Rep. Joe Pitts (R-PA), chairman of the Subcommittee on Health took exception with this definition, claiming that in the strictest sense of the phrase, software is not in fact a medical device.
Shuren’s concern remains that if current draft legislation is passed, higher risk applications of mHealth would no longer fall under the jurisdiction of the FDA. Testimony from that hearing is available here.