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Most Health Phone Apps Not Subject to Regulation, FDA Official Says

By Emily Ethridge, CQ Roll Call

March 21, 2013 -- The Food and Drug Administration (FDA) will not regulate smartphones, tablets, and most mobile health applications and is not inclined to put the items in a category that would subject them to a tax, an agency official told lawmakers.

House Energy and Commerce Republicans devoted three days this week to hearings looking into FDA regulation of mobile medical applications, and whether those items could be subject to a medical device tax in the 2010 health care law (PL 111-148, PL 111-152).

GOP lawmakers and some industry officials said a lack of final guidance from the FDA made uncertain how the apps—which can range from calorie counters to devices that turn phones into ultrasound machines—would be regulated.

"The message was clear: We need final guidance. The developers of these apps and the health care industry need certainty," Oversight and Investigations Subcommittee Chairman Tim Murphy, R-Pa., said at the hearing.

Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, tried to reassure lawmakers that the agency intends to regulate only a narrow subset of mobile medical applications.

Those applications must meet the definition of "device" under FDA law, and either serve as an accessory to an already-regulated medical device or turn a mobile platform into a regulated device. She also said the agency's policy would not involve regulation of smartphones or other platforms for mobile medical apps.

"It would not regulate the sale or general consumer use of smartphones or tablets," Foreman said.

Foreman said the FDA would concentrate on regulating applications that could pose a risk to patient safety if they do not work as intended. That means the agency would not focus on products meant to guide someone on a healthy lifestyle, such as pedometers or calorie counters.

In addition, products not intended to diagnose a disease or condition, or to cure, mitigate, treat or prevent a disease are not considered medical devices, the FDA says.

"We intend to strike the right balance," Foreman said. "We are actually refining our regulatory approach, rather than overreaching."

The final guidance on regulation of the apps will come out by the end of this fiscal year, Foreman added. A draft guidance, released July 2011, caused much consternation in the industry. An FDA user fee law (PL 112-144) enacted last year required the Health and Human Services Department to collaborate with other agencies and post a proposed regulation strategy online.

Several Republicans asked whether the FDA regulation of the mobile apps could lead to apps or smartphones being taxed as medical devices under the health care overhaul. Republicans say the medical device tax will hurt innovation by preventing companies from investing in new products.

"This isn't about scaring people into thinking this tax will apply to their iPhones, Blackberries or iPads, but this tax could absolutely halt the development of new apps to run on those devices," Murphy said.

Foreman noted several times that the IRS, not the FDA, has control over implementing tax policy. But she said the agency did not intend to list smartphones as medical devices.

"They would not be regulated as medical devices, therefore not subject to the medical device tax," Foreman said.

Democrats chided Republicans for pursuing the question at hearings over the past three days. Henry A. Waxman, D-Calif., noted that the health care law says that any devices generally bought by the general public at retail for personal use are exempt from the tax.

"Thank goodness the myth of the iPhone tax has now been put to rest," said subcommittee ranking Democrat Diana DeGette of Colorado.

Foreman also addressed concerns that the FDA is hindering industry by taking too long to review submissions for medical mobile apps.

"This is not new for the FDA. We've been regulating software and mobile apps for some time," Foreman said.

According to a letter the agency sent to committee members, the average time in 2011 and 2012 for FDA review of medical device submissions with a mobile medical app was 67 days. The average total time from submission until an FDA decision was 110 days.

Foreman added that the FDA gets fewer than 20 submissions a year with mobile medical apps—about 0.5 percent of all medical device applications it reviews.

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