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

In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA has waited.

FDA will actively regulate only the small portion of mobile medical applications that present the same risks as conventional FDA-regulated 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Sticking to a policy outlined in its 2011 draft guidance, the agency will apply enforcement discretion to a long list of lower-risk app types, even if they

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