FDA releases details of Apple device meeting in response to FOIA request
The FDA released details of its meeting last December with senior Apple executives about new mobile products, sensors and a glucometer. During the meeting, Apple representatives said the company had "a moral obligation to do more with sensors."
The topics and tone of the discussions released by the regulatory agency were in response to a Freedom of Information Act request made by AppleToolbox, an online media publication that covers technology. The FDA disclosure came just a week after Apple unveiled its mobile health and fitness platform, called HealthKit, for iOS 8 and Mac. HealthKit pulls together data collected by mobile apps on the iOS.
The agency said that in the meeting, which included Commissioner Margaret Hamburg and Apple's Senior Vice President of Operations Bud Tribble and Vice President of Worldwide Government Affairs Michael O'Reilly, company officials said they see their mobile technology platforms with added sensors as an "opportunity to do more with devices, and that there may be a moral obligation to do more."
There is widespread speculation in the medical device and technology industries that Apple--as does Google with its Google Glass wearable internet-connected glasses--plans to offer a glucose monitor sensor in the future. The platform for Apple's blood-sugar monitoring sensor will likely be the iWatch, which has yet to be unveiled.
With respect to a glucometer, the FDA said in the meeting with Apple that it regulates on the intended use of a device. If the intention is that the device would be used to monitor blood sugar for the purpose of better nutrition, then it would be unregulated. However, if the device were marketed to diabetics, "it would more likely be regulated as a medical device."
"Under the current regulatory scheme, FDA will review a device based on the manufacturer's intended use for the device," the agency said in the meeting. "With regards to sensors, the presence of a particular sensor will not necessarily lend the device to FDA regulation. Instead, FDA would be more likely to regulate the software that puts the sensor to use, if use of the software alters the device's use to be a medical device."
Apple said it will work closely with the FDA as it develops future products.