Developers of mobile medical applications are increasingly encroaching onto territory traditionally overseen and regulated by the US Food and Drug Administration (FDA), and the overlap is causing an uncomfortable friction between developers used to oversight-free development and FDA's legislative mission to protect consumers, reports Politico.
The emerging clash follows FDA's promulgation of draft guidance in July 2011, when it proposed some basic regulatory principles for mobile medical application developers. Those principles include which apps would-and which apps would not-be regulated under FDA's authority, FDA's regulatory approach toward those applications, general categories for mobile medical applications and corresponding levels of anticipated FDA regulation, and regulatory requirements for developers and manufacturers of applications.
"That seemed reasonable enough to the traditional medical-device industry, which is well-versed in the ways of the FDA," explained Politico. "But the requirements - data on effectiveness, possibly clinical trials - have gobsmacked some software developers who are used to working in the fast-paced, relatively unregulated wilds of the Internet."
"It's a regulatory clash that grew out of a burgeoning revolution in medical technology," remarks Politico.
The regulations also call into question marketing practices. If an app advertises it can help patients lose weight if they follow its specific regimen, is the app itself subject to a claim about efficacy, or is the regimen-perhaps a specific diet-subject to that claim?
FDA said it is trying to strike a delicate balance between the need to innovate and the inevitable emergence of charlatans seeking to profit at the expense of consumer health.
"We're trying to come up with a policy that addresses some of the concerns people have and provides clarity," said Bajul Patel, a policy advisor to FDA. "What the agency is trying to avoid, for instance, are the bad actors who might claim a device that shocks you 'is good to use as a pacemaker.'"
Some congressmen, however, are pressing for FDA to speed up its process and make it more transparent. In a letter sent to FDA and the Federal Communications Commission (FCC) 11 April, six Republican Representatives cautioned both agencies against issuing "slow and inconsistent regulations."
"These new technologies increasingly cross two regulatory structures," the Congressmen state in the letter. "It is critical that the [FDA and FCC] act in concert to provide regulatory predictability, consistency, and swiftness so that needed innovation in wireless medical technology may thrive."
Politico - FDA tangles with wireless medical-app makers
FDA - Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications
Regulatory Focus - Congressmen Pressure FDA, FCC Over Wireless Health Regulation
mHealth Regulatory Coalition