Emails between Apple and FDA hint at future plans

“Since its well-publicized meeting with the FDA in 2013, Apple has continued to meet with the agency regularly as well as to correspond by phone and email, according to emails obtained by MobiHealthNews via a Freedom of Information Act request to the FDA,” Jonah Comstock reports for MobiHealthNews.

“These emails show that Apple and the FDA have discussed the App Store review process, the 510(k) process, ResearchKit apps, diagnostic apps, working with the FDA in an ‘unregulated’ way and more. The FDA even invited Apple to participate in regular briefings designed to help guide an international effort to harmonize medical software regulation,” Comstock reports. “Though much of the sensitive information is redacted, the emails also point to three regulated medical devices that Apple is seriously pursuing: an app for diagnosing Parkinson’s disease and two separate but related cardiac devices. Finally, the emails also suggest that, after Apple received a good deal of press for its 2013 FDA meeting, the agency worked with Apple to keep future meetings under the radar.”

Comstock reports, “Apple’s plans for two cardiac devices and a Parkinson’s diagnostic app are a glimpse at what’s next for the company’s steady move into the medical world.”

Read more in the full article here.

MacDailyNews Take: </strongYes, it looks like Apple expects and is prepared to be crossing over the FDA’s regulatory line sooner than later.

Why Apple is now collecting some medical data from iPhones – March 31, 2016
How iPhone CareKit apps will revolutionize health care – March 25, 2016
Apple advances health apps with CareKit – March 21, 2016


  1. I met with a person who is on the board of a startup with a “Cardio App.”

    He held his iPhone camera to his chest for a minute and the screen then reported the cardiogram, pulse, oxygenation and blood pressure. I don’t have an idea of accuracy, but it looked good.

    He said the app was put on the the iOS app store and quickly the FDA called and said “That is a medical device; take it off.” The company replied that it was a fitness monitor. FDA didn’t “buy it” so it is off the app store.

    The rumor is the company is now working with Apple, but like so many rumors, “working with” doesn’t mean it is going to come to market anytime soon. FDA clearance can be lengthy.

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