Great Recap by Brian Ahier on This Week’s Mobile Health FDA Hearings

The outcome of the hearings is:

Also providing testimony was Ms. Christy Foreman Director, Office of Device Evaluation, Center for Devices and Radiological Health at the FDA. She said: “Just as importantly as what our policy proposes is what our policy does not propose. It would not regulate the sale or general consumer use of smartphones or tablets. It would not consider entities that exclusively distribute mobile medical apps, such as the ‘iTunes App store’ or the ‘Android market,’ to be medical device manufacturers. It would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA. It would not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes. And, it would not apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system.”

via Brian Ahier

Great Recap by Brian Ahier on This Week’s Mobile Health FDA Hearings