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On December 12, 2013, five Apple executives met with four Food and Drug Administration officials in Washington DC. At the time, the topic of the meeting wasn’t made public. But thanks to documents obtained through the Freedom of Information Act by Apple Toolbox, we can now read a summary memo. In short: They were talking about what specifically would trigger FDA regulation of, say, a purely hypothetical Apple wearable device.
The document made available through FOIA is a summary, not a transcript — so we don’t know which comments are attributable to which participants. The meeting only took an hour, but one thing was made clear: Apple wanted to work closely with the FDA during the development of unannounced products in order to avoid regulatory speedbumps. If Apple were to release a product with a new kind of sensor, such as a glucose meter — which was specifically discussed — that wouldn’t necessarily trigger regulation, but if the product were then marketed to diabetics, for instance, the FDA would need to take action. From the memo:
“FDA will regulate 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.”
The subtext throughout this entire discussion was Apple’s still unconfirmed wearable device, which is expected to be launched at an event this October. The memo provides further evidence that Apple is working on a product that might include a variety of health sensors. But we still don’t know how Apple will market the device or what it will be able to do.
Using the glucometer example, some people need to monitor and log blood glucose levels. If Apple’s device can take readings and record the logs, a lot of diabetics would find it extremely handy. But, if I’m interpreting the memo correctly, Apple won’t be able to take out an ad in Diabetic Living to tout those “off-label” features directly to patients. Apple might be forced to use “fitness” as the marketing point when the device launches, in order to infiltrate the highly regulated medical device market while avoiding scrutiny. But the major challenge to consumer-grade medical devices still applies: eventually, in order for doctors to prescribe an Apple device or app, it will need some form of medical approval.