FDA Emphasizes “Deregulatory” Efforts In Mobile Medical Apps Final Guidance

Article preview from "The Gray Sheet" - September 23, 2013

When it comes to regulating mobile apps, “it’s not about the platform, it’s about the functionality,” says CDRH Director Jeffrey Shuren of the long-awaited mobile medical apps final guidance.

FDA Emphasizes “Deregulatory” Efforts In Mobile Medical Apps Final Guidance

Article preview from "The Gray Sheet" - September 23, 2013

FDA will actively regulate only the small portion of mobile medical applications that present the same risks as FDA-regulated conventional devices, the agency affirmed in the much-anticipated mobile apps final guidance issued Sept. 23.

Sticking to a policy outlined in its 2011 draft guidance, the agency will apply enforcement discretion to a long list of lower-risk app types, even if they might technically meet the definition of a medical device.

Digital health firms and others have been anxiously awaiting FDA’s final policy on the regulation of mobile medical apps since the release of its draft guidance. FDA received more than 130 comments on the draft, most of which commended FDA’s risk-based approach, but sought more examples of the types of apps that would be regulated.

“The final guidance keeps the same core policy, but provides clear explanations and more examples,” CDRH Director Jeffrey Shuren explained in a Sept. 23 press call.

“Consistent with the FDA’s existing oversight approach that considers functionality rather than platform, the FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended,” FDA states in the final guidance released Sept. 23.

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