We know that Apple was in a health-oriented talk with the U.S. Food and Drug Administration last December, but the specifics of that discussion were not revealed until this morning. Three months after filing a Freedom of Information Act request, Apple Toolbox has received an official response from the FDA about what it talked about with the world’s most valuable tech corporation. Read ahead for highlights from the conversation…
First and foremost, Apple thanked the FDA for their mobile medical apps guidance. Under this guidance, the FDA indicated that it “does not view apps that are purely educational or informational as medical devices.” Instead, these apps would be considered diagnostic. The FDA provides a glucometer as an example, noting that the display screen of the glucometer would not be regulated, but rather the software that does the measuring.
Apple has agreed to work closely with the FDA on the development of future products. The earlier that the FDA can play an advisory role for the company, the less likely that Apple will be caught by surprise if the product must be regulated. Again, if you put one and two together, these talks could equate to Apple looking to get FDA approval ahead of launching the oft-rumored iWatch later this year.
Apples sees potential in mobile technology platforms as an opportunity for people to learn about themselves, especially with the possibility of future mobile devices having more built-in sensors. Apple already has its brand new Health app and HealthKit platform, and the so-called “iWatch” could be one of the sensor-equipped devices it speaks of. The company feels morally obligated to work on these products.
There is a very fine line for the FDA regulations of health-related devices based on their intended use. For instance, using a glucometer would likely be unregulated if it is intended for a user to maintain a certain blood sugar level for the purposes of better nutrition. If such a device was being marketed to diabetics, however, it would likely be regulated as a medical device.
Apple is expected to unveil its first wearable device in October.