Apple’s FDA Meeting Addressed Regulations For Health, Possible New Products and Sensors
Several Apple executives, lead by Senior Vice President of Operations Jeff Williams, met with members of the U.S. Food and Drug Administration (FDA) in December.
The company discussed mobile medical applications during the meeting with FDA Commissioner Margaret Hamburg in Washington, DC.
After the meeting was over, AppleToolbox filed a Freedom of Information Act with the FDA, asking them for details of the meeting. Three months later, the FDA responded with a memo, which outlines the highlights of the meeting. Here is a snippet from the memo:
” Apple sees mobile technology platforms as an opportunity for people to learn more about themselves. With the potential for more sensors on mobile devices, Apple believes there is the opportunity to do more with devices, and that there may be a moral obligation to do more.
Sensors already exist on medical devices. For instance, Apple’s devices have cameras and accelerometers. There is still an opportunity to innovate, but Apple wants to make sure they are on the side of the FDA.”
While there was no specific mention of any device that Apple may currently be developing, it is clear that Apple is looking to keep an open dialogue with the FDA as the company looks to make an impact on the health monitoring industry. The memo also mentioned a glucometer while discussing which aspects of health monitoring technology the FDA would regulate.
“FDA will regulated based on the intended use of a device. Using the glucometer example, the glucometer may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition. If the glucometer is marketed for diabetics, however, it would more likely be regulated as a medical device. FDA looks at how devices are actually used. If the manufacturer advertises the device for an unapproved use of FDA sees a lot of off-label use that is potentially dangerous, FDA may regulate after the fact.”
At WWDC Apple unveiled Health, an app for iOS that allows users to track their health and fitness data, and HealthKit, an API for developers and manufactures to use to integrate their hardware with the Health app.
The company is expected to launch a health and fitness-focused device, dubbed the iWatch, at an event later this year (possibly alongside the next-generation iPhone).