A year ago Apple met with the FDA and rumors started swirling about health-related products and services. Now, a successful “freedom of information” request from the FDA has produced a summary memo of that meeting. Here are the main points they covered:
- Apple describes the mobile medical application guidance as fair and balanced.
- Apple says that there is a “moral obligation” for companies like itself to push the boundaries and do more with mobile devices to help consumers’ health.
- Sensors should not automatically make a device an MMA, Apple desperately wants to avoid having to go through the overhead of a 510(k) certification.
- The FDA confirms that simply having a sensor, if it doesn’t get used as a medical device as defined in the MMA guidance, will not make the device regulated.
- The FDA explains the difference between “diagnostic” (regulated) and “informational” (not regulated).
- The FDA explains the effect of off-label usage of devices and how marketing for a specific purpose can make a device either regulated or not regulated.
- Apple made it very clear that it will be working closely with the FDA with the goal of avoiding 510(k) certification. It expects the FDA to warn it if there are issues, which may or may not happen.
In an update to the list of apps under “regulatory discretion” the FDA has included one that sounds like it was added specifically for Apple:
Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014].
For healthcare marketers this is about as clear as it gets. If your app collects data for later use with an HCP then you’re not regulated, but if your app provides diagnostic or treatment advice then you better learn how to get through 510(k) certification.
Other news from MobiHealthNews:
- Rumor: iWatch will launch in October, add Cleveland Clinic as partner
- ACOs, digital health companies petition new HHS secretary to derestrict telehealth