Pillsbury Winthrop Shaw Pittman

FDA draft guidance would ease regulatory burdens for certain mHealth applications

By Erica Kraus and Kristi V Kung

On 1 August 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices — including certain mobile applications that can convert a cell phone into a medical device, such as a thermometer or a stethoscope. Although the guidance is not yet legally enforceable, the FDA also announced its intention not to enforce compliance with premarket review requirements for these devices and noted that it did not expect manufacturers to submit 510(k)s for these devices prior to adoption of a final rule or order. The FDA’s recognition that these devices are sufficiently well understood and do not present risks that require premarket review to ensure their safety and effectiveness — and its corollary decision to exercise enforcement discretion as to these devices — eases the regulatory burden on medical application developers and expands opportunities for continued development and dissemination of important mobile tools for improving patient care and physician practice.

Mobile applications are already changing consumers’ approach to healthcare and empowering them to take a more active role in managing their health; one study found that in 2013 there were approximately 31,000 health-related apps on the market. Even Congress can agree on the promise of mobile health applications. In the past year, both the House and the Senate introduced bills to direct FDA oversight toward products that pose a potential risk to human safety, while limiting the regulatory authority over low-risk, information-based applications.

The promise that comes with this rapid technological development, however, has challenged regulators charged with protecting the health and safety of the public, as innovation has often outpaced their ability to issue timely policies and maintain appropriate oversight. This challenge is particularly demanding for regulators contemplating oversight of the thousands of mobile health applications flooding the Apple app store and similar marketplaces each month. Quick access and low cost are two driving factors behind mobile app success — two elements that do not align with a high regulatory approval threshold and long review periods…

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