FDA: Final mobile medical app guidance expected by end of fiscal 2013

Oversight to focus on small subset of apps, official says
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In testimony last Thursday before the House Energy and Commerce Subcommittee on Oversight and Investigations, the U.S. Food and Drug Administration reassured Congress and the mHealth industry at large that the focus of the regulatory agency's oversight will be on a "small subset" of mobile medical applications.

Christy Foreman, FDA's Director of the Office of Device Evaluation, testified that the agency's "narrowly tailored approach" would not require active FDA oversight of many apps that do not meet the definition of medical "device" under the the Federal Food, Drug, and Cosmetic Act.

"FDA believes it is important to adopt a balanced, approach to mobile medical apps that supports continued innovation, assuring appropriate patient protections," stated Foreman. "We believe that focusing FDA oversight on a narrow subset of mobile apps will encourage the development of new products while providing appropriate patient protections."

She also said that "while many mobile apps carry minimal or no risk, others can pose significant risks to patients if they don't operate correctly." Foreman asserted that in some cases those risks are "identical to an already marketed medical device," such as a mobile app that affects the programming of a drug infusion pump or CT scanner that could lead to a drug or radiation overdose.  

FDA's proposed mobile medical apps policy "would not regulate the sale or general consumer use of smartphones or tablets," Foreman assured lawmakers. "It would not consider entities that exclusively distribute mobile medical apps, such as the iTunes App store or the Android market, to be medical device manufacturers."

Additionally, she said the FDA's proposed MMA policy "would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA." Moreover, in her testimony, Foreman said the agency's proposed policy "would not require mobile medical app developers to seek agency re-evaluation for minor, iterative product changes," nor would it "apply to mobile apps that perform the functionality of an electronic health record system or personal health record system."

On Wednesday, the FDA came under fire in another subcommittee hearing for being slow to finalize the agency's draft guidance for mobile medical applications, which critics charge remain unclear and unpredictable. FDA released draft MMA guidance in July 2011, for which it received more than 130 written comments, but has yet to finalize the document. 

Foreman told lawmakers last week that the FDA will issue its final guidance on MMAs by the end of fiscal year 2013. She said the agency recognizes that mHealth app developers and manufacturers need a "clear, predictable, and reasonable understanding" of the FDA's expectations.

Rep. Dr. Michael Burgess (R-Tex.), vice chairman of the subcommittee said that "uncertainty of pending regulation" from the FDA is a major obstacle to innovation and investment in the mobile healthcare industry. Burgess also expressed concerns that the regulatory agency might not be up to the challenge of regulating mobile medical apps.

"The FDA struggles to maintain their current regulatory charge," he stated. "We need to be assured that they have the experience and they have the expertise to handle the additional responsibilities of an emerging market."

Foreman reminded the subcommittee that the FDA has been "regulating medical device software for decades and medical device software on mobile platforms for more than ten years." To date, she said the agency has reviewed about 100 mobile medical apps, including remote blood pressure, heart rhythm, and patient monitors, as well as smartphone-based ultrasounds, EKG machines, and glucose monitors.

Over the past three years, Foreman stated that on average it has taken 67 days for the FDA to review mobile medical apps, which is within the statutory 90-day timeframe under the 510(k) process.

Last Thursday's hearing concluded the third and final subcommittee hearing on mHealth held this week by the House Energy and Commerce Committee.

To learn more:
- read written testimony from hearing

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