Medical App Developers Struggle To Prepare for Regulation From FDA

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Software developers are struggling to prepare for FDA regulation of mobile medical applications, Politico reports (Norman, Politico, 4/16).

Background

Last year, FDA released a set of proposed guidelines on the regulation of certain mobile medical apps. According to FDA officials, oversight is necessary for apps that pose risks for patients if they do not work as designed.

FDA officials said that just a small number of the thousands of mobile apps would face agency scrutiny under the draft guidelines. FDA is seeking to regulate apps that:

  • Are accessories to devices that FDA already regulates;
  • Turn a mobile communications platform into a medical device; or
  • Offer suggestions about a patient's diagnosis or treatment (iHealthBeat, 7/19/11).

The proposed regulations might require data on the effectiveness of mobile medical apps, as well as clinical trials.

FDA has said it does not plan to regulate health and wellness apps.

Challenges for Developers

Many app developers are not accustomed to being regulated by a government agency like FDA. They are used to working in the fast-paced and somewhat unregulated Internet sector, so taking the time to conduct clinical trials or demonstrate effectiveness could be challenging, according to Politico.

In addition, some developers have expressed concern that FDA regulations will restrict their ability to advertise the medical benefits of their apps.

Bakul Patel -- an FDA policy adviser leading the agency's efforts on app and wireless device regulation -- suggested that a developer could make claims about an app's medical benefits if the app were registered with FDA and if scientific literature supported the claims.

The mHealth Regulatory Coalition has asked FDA to delay finalizing its draft guidance on certain aspects of the mobile medical app regulations, saying the agency first should develop a strong framework that can support innovation in the sector (Politico, 4/16).


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