When we first learned that a small team of Apple executives met with FDA officials last December to discuss mobile medical applications, it seemed likely that the discussion was intended to help Apple better avoid FDA regulation for its rumored health products. Thanks to a successful Freedom of Information Act request from the Apple-focused resources site Apple Toolkit, the FDA has furnished a summary memo about their meeting with Apple last year.
MobiHealthNews reviewed an undoctored copy of the original memo and we also reached out to the FDA for some clarification.
The FDA shared seven bulleted points in its summary memo of the discussion. Based on my reading of the memo and with a hint from the FDA, it seems like the first three bullet points were summaries of things Apple said, while the fourth, fifth and sixth were summaries of statements made by the FDA. The final bullet point also appears to have come from Apple.
First, the niceties: Apple thanked the FDA for the mobile medical app guidance, which they characterized as fair. Apple also defended the FDA to Congress and told them that they thought the guidance was balanced.
Second, Apple explained its potential "moral obligation" to do more in digital health: Apple told the FDA that while the guidance was balanced, "industry is always going to be pushing the boundaries. 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," the FDA's Jeff Shiffman wrote in the memo.
Third, a confusing and curious summary bullet: "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." Apple doesn't have medical devices, it sells mobile devices that are not regulated as medical devices -- and its mobile devices have cameras and accelerometers in them. The third sentence seems to indicate that Apple wants to stay on the unregulated side of the FDA, but an FDA spokesperson told MobiHealthNews in an email that the sentence is "meant to convey the discussion at the meeting that captured Apple’s intent to ensure that potential projects align with applicable FDA regulation and guidance."
Fourth, the FDA explains how intended use affects regulatory status: "Under the current regulatory scheme, FDA will review a device based on the manufacturer’s intended use for the device. 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." Just speculating, but this reads as if Apple asked about how the addition of a particular kind of medical sensor could change the regulatory status of a wearable device, like the rumored iWatch. As written, it sure sounds like Apple is looking to avoid regulation.
Fifth, the FDA explains how a medical device is diagnostic and not simply informational: "The current mobile medical app guidance indicates that FDA does not view apps that are purely educational or informational as medical devices. Apps that actively measure something are considered diagnostic. For instance, a glucometer would be considered diagnostic because it measures blood sugar; it would not be considered merely information although it 'informs' the user of the blood sugar level. The display screen of the glucometer would not be regulated, as it only receives the data and shows it. The software that does the measuring is the part that is regulated." Now that we know HealthKit and Apple's Health app display glucose data from third party apps and, assumedly, third party medical devices, it is possible that was why they discussed glucose data with the FDA. Or the FDA just used it as an example, as it often does.
Sixth, the FDA further explains intended use and how off-label use might affect regulatory status: "FDA will regulated [sic] 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 [sic] FDA sees a lot of off-label use that is potentially dangerous, FDA may regulate after the fact." This glucometer example sounds more and more like the FDA's example of choice, not Apple's.
Seventh, Apple promises to work with FDA to avoid regulatory surprises: This one is particularly telling. Apple seems to want to avoid developing a regulated medical device unintentionally, so it has promised to keep the FDA posted on progress on its health products under development. "Apple will work closely with FDA as they develop future products. The earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated."
While it seems like the FDA officials did most of the talking, Apple may have tipped its hand a bit about its desire to remain unregulated by the FDA. That, of course, will limit how the company advertises its rumored iWatch. It probably won't be able to pitch it as a device that helps a user manage any particular chronic conditions and it can't claim that the iWatch could diagnose a wearer with any kind of medical issue. There are indications that Apple is thinking about its health-related products as medical ones though -- the FDA memo reveals the title of Dr. Michael O'Reilly, the former Chief Medical Officer at medical device company Masimo, as Apple's Vice President of Medical Technologies.
It's also worth emphasizing: Apple told the FDA that "industry is always going to be pushing the boundaries", so you can bet it will be positioning its rumored device and its already announced health tracking platform right at the edge of what the FDA considers a regulated medical device.