Guidance for Mobile Medical Apps

Mobile platforms have become more user friendly, computationally powerful, and readily available and as a result, innovators have developed mobile apps of increasing complexity. As in the case with traditional medical devices, certain mobile medical apps can pose potential risks to public health that are unique to the characteristics of the platform on which the mobile medical app is run.

For example, the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and the uncontrolled ambient light on the mobile platform.

To understand FDA’s position, FDA on February 9, 2015 published the document “Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff”. For questions about the document contact Bakul Patel at 301-796-5528 or email Bakul.Patel@fda.hhs.gov.

Go to www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf to view the document.

 

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