The U.S. Food and Drug Administration (FDA) and members of Congress are at odds over whether software should be regulated as a medical device.
Both sides of the argument were made at a hearing held Nov. 19 by the House Energy and Commerce Subcommittee on Health which examined federal regulation of mobile medical apps and other health software.
Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, testified that the agency's regulation of software (mobile apps) as a medical device is based on risk and function (their intended use). Shuren emphasized that the FDA regulatory approach treats devices that perform the same function the same way regardless of the platform on which it is used.
"It's not about the platform. It's about the function," said Shuren. "The issue has come up when someone develops software and they use the smartphone, let's say, that suddenly gives it a medical function…the software is the issue."
How software becomes a medical device is through "intended use and diagnosis of disease and conditions or treatment cure mitigation of disease," he said.
Nevertheless, at the hearing, members of the subcommittee took issue with the FDA regulatory approach to software.
"In September of this year, the FDA put forward a proposal, in the form of final guidance [on mobile medical apps], indicating that software was a medical device for the purposes of regulation--except that software is not a medical device," Rep. Joe Pitts (R-Pa.), chairman of the Subcommittee on Health, said. "To regulate it as such, the FDA has said it will use [enforcement] discretion to decide which software to regulate. Except that no matter what Dr. Shuren tells this committee here today, there is no guarantee that his successor won't go back on this guidance tomorrow."
At the center of the disagreement between the FDA and some members of Congress is the SOFTWARE Act, a bipartisan bill that was introduced late last month by Rep. Marsha Blackburn (R-Tenn.), vice chair of the House Energy and Commerce Committee, to amend the Federal Food, Drug, and Cosmetic Act to regulate medical software. The bill establishes three categories of software--clinical, health and medical--with the two former software types not subject to regulation under the proposed legislation.
"It is Congress' prerogative to pass legislation. That is certainly your choice to make," said Shuren. However, he warned that the SOFTWARE Act "takes out from our authority the ability to assure the safety and effectiveness of devices that we currently regulate including some high risk devices."
For example, Shuren testified that if the SOFTWARE Act was passed into law as currently drafted, the FDA would no longer be able to assure the safety and effectiveness of blood glucose meters and software that is used to analyze pap smear slides. He said that in his opinion it was "premature" for Congress to pursue legislation like the SOFTWARE Act on the heels of the FDA's September release of its final guidance on mobile medical apps.
"It's very confusing to us what this actually accomplishes," he added. "Now, we're not saying there isn't going to be a need for legislation at some point. There may well be. But, we think at the present time it's just simply premature."
One area that was not addressed by the FDA's final guidance was clinical decision support software, which will be addressed in a congressionally-required risk-based regulatory framework for health IT, including mobile medical apps. Currently, the FDA is working with the Federal Communications Commission and the Office of the National Coordinator for Health IT to finalize a report to Congress with the framework and recommendations.
The FDASIA-mandated report to Congress was to be delivered by January 2014. However, Shuren said that February is a more realistic timeframe.
To learn more:
- read testimony from hearing