You might have heard that Congress recently passed legislation that promotes FDA regulation of mobile devices. It’s actually a bit more complicated than that. Congress was instead considering a bill that would muddy the regulatory waters for mobile app developers and distributors as well as smartphone and tablet manufacturers.
Here’s what happened. Every five years, Congress authorizes FDA to collect fees from the companies it regulates. Legislators usually add provisions that affect how FDA functions. This time around, the legislators managed to get at least one provision right—one that will promote the use of mobile medical apps.
To appreciate the provision’s importance, you have to go back to July 2011, when FDA published a draft guidance describing its approach to regulation of mobile apps that meet medical device definition. The agency described certain mobile apps that would not be regulated at this time, despite having the legal authority over them. These include electronic medical textbooks, training tools, and general health & wellness apps, among others. The purpose was to promote innovation and development of these types of apps. But to address patient safety concerns, FDA stated its intention to regulate mobile apps that connect to a medical device, transform a mobile platform into a device, or produce a patient-specific output.
Fast forward to earlier this year; Congress included in the new FDA user fee bill a moratorium on the publication of the final guidance. Numerous stakeholders, including FDA, charged that the lack of guidance would create uncertainty in the market and would prevent innovation. Worse yet, the provision would effectively force the agency to regulate all mobile medical apps. Thankfully, reason won the day and the provision was pulled at the last minute. What remained was a requirement that FDA, along with FCC and ONC, publish a report that describes its approach to regulation of all health IT.
Now FDA can publish the final guidance and focus on the broader regulatory framework.
[M. Jason Brooke, JD works for the firm Epstein Becker Green in Washington D.C. An associate in the Healthcare and Life Sciences practice, he develops policy on the FDA regulation of mobile health technology and counsels mobile health companies on FDA regulations.]