Senators ask for clarity on mobile medical apps

A bipartisan group of senators asked the Obama administration Wednesday whether additional legislation would ease its task in regulating mobile medical applications.

The group of six lawmakers praised the Food and Drug Administration for adopting a risk-based approach to governing the apps, and asked the agency to provide more details about its plans for rule-making.

{mosads}The letter asked whether additional statutory definitions could help “clarify any uncertainty with respect to assigning risk level of medical software.”

“While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated,” the senators wrote to FDA Commissioner Margaret Hamburg. 

The letter followed the publication of guidance for mobile medical apps in September. The FDA stated that its “tailored” approach to regulation will only apply to devices that are “intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device.”

The guidance assuaged some fears that the FDA would aim to regulate any health-related mobile apps as medical devices.

Wednesday’s letter came from Sens. Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Mark Warner (D-Va.) and Richard Burr (R-N.C.).