FDA to Focus on Apps With Greatest Medical Risk to Patients

The FDA reported Monday that a majority of mobile apps will not be enforced under the Federal Drug & Cosmetic Act — apps like disease journals, tracking logs, carb counters, etc. as they pose a minimal risk to patients.

However, mobile medical apps, which can carry significant risks if not operated properly, will be assessed using the same regulatory standards and risk-based approach that the FDA applies to other medical devices.

The FDA has cleared about 40 mobile medical apps in the past two years alone.

eHealthcare Solutions can help both publishers and marketers by either monetizing your mobile app or reaching your target audiences who use them. Contact us to get started.

Read more.