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What Apple Watch's FDA clearance really means



Yesterday, Apple announced that the US Food and Drug Administration removed two new features for the Apple Watch Series 4. One is an advanced method of monitoring the heart called an electrocardiogram (ECG) and the other is Watch's ability to detect and alert the user about an irregular heartbeat. Both features will be available on your device later in 2018 (not at launch). The news sounds exciting, but there are some important reservations that limit how useful the new gadget will be.

Firstly, the FDA clearance letters for both ECG and irregular rhythm alerting notice that they are not intended to be used by persons under the age of 22. The irregular rhythm is not intended for people who have previously been diagnosed with atrial fibrillation, which is one of the common causes of an irregular rhythm. (In other words, this feature is best used by people who already do well.) And both letters indicate that the apps are "not meant to replace traditional methods of diagnosis or treatment." They can provide additional information and that the information may be useful, but they will not replace a doctor's visit.

Secondly, it is important to understand that the FDA has "cleared" both apps, but it is not the same as "approving" them. There are usually three ways to get the FDA involved in a new project, according to Jon Speer, co-founder of Greenlight Guru, a company that manufactures quality management software for medical devices. The most advanced is FDA approval, which is only made for Class III products, or technologies that may be at higher risk, but also a higher advantage. (Think: Implantable Pacemakers.) Approval is the Gold Standard, and businesses need to do a lot of tests to receive this term.

Apple Watch is in Class II. For Class II and Class I, the FDA does not give "approval", it only gives clearance. Class I and Class II products are products with lower risk ̵

1; as Speer says, it's a Class I class like a heavy depressor – and it's much easier to get approval than approval.

For the most part, products are removed because they are sufficiently similar to an existing medical device that the FDA has already regulated. However, Apple has emphasized that it has received a "de novo" classification for the ECG function. That means, although it is still in Class II with regard to risk and has not gone through as much testing as an "approved" device, it is unlike anything else on the market. It is the first direct-to-consumer ECG laptop. (Last year, FDA approved AliveCor KardiaBand, a clock device that essentially does the same, but it was not direct to the consumer.)

Historically, something about "de novo" claims a less common way of getting devices to market, but it is becoming increasingly popular, adds Speer, as we mix training machines with new technology. "We will continue to see these usable technologies crossing over and being regulated as medical devices," Speer says. "Think of things that are indicators of your health: blood pressure, heart pressure, respiratory rate, maybe things like diabetes treatment. The possibilities seem endless."

As one example, Omron has worked with a blood pressure monitor that looks like a smartwatch. Last year, the EU announced that Natural Cycles Fertility Tracking App could be classified as a medical device. (This may not have been a wise decision, given the controversy around the app.)

"It was a time when technology companies were not interested in health care and not ready to play ball," said Linda Pissott Reig, co-chairman of FDA part of law firm Buchanan, Ingersoll & Rooney. Now we have Apple to embrace health care and this professional announcement, and the FDA is more open to approving these new technologies. Reig points out that the FDA approved the two new features only about one month after the application was first submitted. "Having had this success in short order with the FDA responding to their application will encourage others to follow in their way and to be encouraged to these opportunities that the FDA will embrace and bless and allow to continue," she says.


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