FDA to issue mobile app guidance before Oct. 1, official says

The Food and Drug Administration plans to issue final guidance about how it will regulate medical mobile applications before Oct. 1, an agency official told a House Energy and Commerce subcommittee Thursday.

Christy Foreman, director of the office of device evaluation in the FDA's Center for Devices and Radiological Health, said the FDA is finalizing the guidance and expects to release it before the end of the government's fiscal year.

The FDA issued the draft guidance in mid-2011. Delays in the release of the final guidance have prompted criticism from lawmakers and mobile app developers and investors, several of whom provided testimony earlier this week to House Energy and Commerce subcommittees expressing concern about regulatory uncertainty and its impact on the market.

Some medical mobile apps have received FDA clearance in recent years, although the vast majority of the estimated 40,000 health and wellness apps on the market do not require federal oversight.

Many of those apps, including ones that do not require FDA clearance, are starting to be used by hospitals and physicians seeking to better manage the care of their patients, including those who are chronically ill.

“Like traditional medical devices, mobile medical apps may in some cases present significant health risks to patients,” Foreman said in her prepared remarks (PDF). “FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended.”

The goal, Foreman said, is to focus on “higher risk products,” rather than low-risk technologies such as apps that monitor the number of steps a patient takes each day or remind a patient to refill a prescription.

She said the FDA does not plan to regulate sales or consumer use of smartphones and tablets, another issue that was repeatedly brought up by House lawmakers this week.

In addition, Foreman noted that the review process for mobile medical apps takes about 67 days, which is shorter than the requirement that the FDA complete reviews of 510K device applications within 90 days, according to data collected over the past three years.

The hearing this morning capped three days of hearings this week that focused on the development and regulation of mobile medical apps.

In addition, Reps. Fred Upton (R-Mich.), Joe Pitts (R-Pa.) and Dr. Michael Burgess (R-Texas) released a report Thursday through the House Energy and Commerce Committee outlining life sciences-focused policy concepts that it plans to focus on, including the need to protect health apps from the medical device excise tax and “bureaucratic red tape.”