The Apple Watch itself is a "platform" for software applications. FDA does not regulate a "platform." This was a decision made early on when the agency was developing its strategy for software regulation and mobile apps. The platform provides for the use of various mobile app software programs that may be "stand alone" or used in conjunction with other accessories that are part of a medical device system, e.g., sensors used with the phone and the software program required to use the sensors for a medical purpose. The mobile app is deemed a medical device by the FDA based on its "intended use." If the intended use falls within the definition of a device, as put forth in the Federal Food, Drug, and Cosmetic Act, as amended, the article is a medical device. The definition of a medical device is very broad.
ex-Associate Director for Guidance and Government Operations, Center for Devices and Radiological Health, FDA.

I think Casper is technically correct in making the distinction between a 'platform' and a medical mobile app. But I think it misses the point that Mr. Ogbru is trying to convey. This new platform of a wearable mobile device (e.g. Apple Watch) allows the creation of many new medical mobile apps that can access this platform's sensors and provide a continuous monitoring of ones physiology. It maybe true that a mobile medical app is a medical device, however, it is this platform that will provide architecture to develop these new medical apps.

I agree with Flip as well as Caspar.
The Apple watch has clearly the intention to be the platform and selected hardware for building medical devices. But at the end it also must define its intended use and being a platform doesn't make it a medical device.
Strictly speaking all the apps have a problem with the apple watch, since they apple watch is not bound to medical device standards by formal registration. The apps are bound to this hardware, if they use the included sensors. Not like apps, which work with standard smartphones. The medical device applications would be forced to assess the risk of the apple watch infrastructure, to control it and mitigate it. Are they able to do so? No they will not and Apple is not known to be extremely open in sharing their internal information. Strictly speaking they are therefore not able to fulfill the requirements FDA poses normally on software controlling hardware, which can directly harm people. So there is a risk that these apps are no allowed to enter the US market, if the FDA applies the normal level of scrutiny for hardware - software combinations.
At the end the situation is not so different in the EU, even when the EU has no premarket assessment. For higher classes than class I you need a notified body, which can deny you the necessary certificate.
So when the apple watch does not register as medical device, market access for the apps can become very complicated or impossible.

Ee Bin Liew From the regulatory perspective, from all the meetings and discussions I've attended... this is a learning process for everyone. Hard to say which way it's going now but at least it has gotten attention, have an awareness that this is not a fad and will not go away, and it's just something the regulatory framework of today had not truly figured out. Let's us be patient and give more time.

Cheers,
Ee Bin

Denise Dion I think the FDA has made a distinction regarding products that help people pursue a healthy lifestyle and have agreed to not regulate them as medical devices (think FitBit, and the other devices that measure how far you walk, your sleep activity and even your heart rate and calories burned).

Thierry POREE In EU , the Apple Watch itself is probably not a medical device, but combined with some applications for diagnosis, prevention, monitoring, treatment or alleviation of disease or handicap... It will surely be. For example if it alerts the patient when his heart or hypertension rates are too high.
But what should be the case of an alert about environment when it could be dangerous for the patient : too much allergens for allergic peoples, too much fine particles for asthma sufferers... ?

Kaushik Lodh Fads =/= Medical device. A medical device is one that has been approved by FDA through PMA or IDE after 21 CFR 800 series quality, ISO 14971 risk and AAMI HF75:2009 usability certifications.

iWatch, iPhone, iPort-a-potty are not medical devices, and are gimmicks. They can be a part of a wellness device paradigm, but they do not meet requirements to be a standalone wellness device, let alone a medical device.

Matthew Bodo I don't believe there is (notwithstanding heart rate monitor functionality) but that doesn't mean there shouldn't be.

I believe that the sensors exist today to measure heart rate, pulse ox, and even blood pressure might exist today at a scale where they could fit in the confines of a watch format, however, I do not believe they are small enough where they could all exist at the same time in the same watch.

Achieving that breakthrough would revolutionize the way HCPs manage patients. Data could be collected real-time, sent to the HCP, pre-analyzed by algorithms designed to detect/predict certain medical conditions, and summons the patient to the doctor's office.

I (briefly) looked into this next generation technology while in graduate school, and presume it would be ready to certify in about 2-5 years https://youtu.be/ar0cj4goadI

The Apple watch is only the latest watch to come out. Smart watches by Samsung, LG, Motorola, that have the same features and more, have been out for years. If there was a company that put in the effort to make their watch a true medical device then I would hope that it would not be from Apple because, unlike some of the other watches, you would be required to own an Apple phone to use it.

Thierry POREE You are true Kaushik for USA where the classification is simple : FDA decides. But in EU and several other countries, my question remains. Who have an advice about that ?

The Apple Watch (note now, that is not "I-Watch') is a fashion product. Apple hired all the medical staff they needed to make a jump into medical devices, but they held off... instead they launched "Research Kit" a program to collect Big Data for Medical Sensors... The problem is defining a new product. It is risky business to define a new product, what sensor fusion would be used with a predetermined relationship in mind.... Who decides really what is the right heart rate, respiration rate, calorie count, etc. and what is right for each person? Providing the ability to collect data is necessary first, then after enough data is collected, we can begin to make assumptions about our sensors and what they are really telling us as opposed to what we think they should tell us. Collect data - then make conclusions - rather than make conclusions and try to find data to support it.

So there you have it, that is why Apple did not come to the market with a "health monitor" instead of a fashion device. Overall all of the announcements that were just made were "me too, Samsung" products, as Apple simply put their stamp on existing products.

The risk-taker who would have brought forward the health monitor was Steve Jobs, these guys aren't going to take any risks, they don't have the guts for it.

Ome Ogbru, PharmD Thanks for all you comments and clarification about the FDA definition of a medical device. Regardless of its classification how will the Apple Watch impact health or how we deliver, monitor or receive health care? Any thoughts?

At the risk of mentioning the obvious, in my opinion the Apple watch will:

1. Act as a catalyst for mainstream adaptation of wearables. The Apple brand and the Apple marketing budget has the best chance to date on making wearables a mainstream product. Predecessors to Apple have largely been serving a niche market mostly comprised of the fit/ health conscious OR techie consumers. The Apple brand makes the iWatch an aspirational product and hence it is more likely to drive broader adaptation. However, I do have one caveat. Not unlike other Apple firsts, its demand will first be driven by early adaptors. As the launch of the next generation device approaches, its MSRP will adjust and make it a more affordable and hence we will begin to see its true effect.

1. With the above, the popularity of the device will sprout application development (something its predecessors have had limited success with). The fact that Apple alone is in the game, is enough for major app developers to have begun work on applications. This will undoubtedly sprout a much larger catalog of health related applications. Remember, that while the business model of selling devices is attractive to Apple, the model is and always will be about the recurring revenue that comes from downloading applications via iTunes. In addition, when Apple first envisioned the iPhone and iPad, they did not need to envision all that it does for us today. All they needed to do is ensure that the HW supported what the application developers envisioned.

1. Apple has already made steps in standing out as an advocate for consumer data security. This effort can be of benefit to drive broader acceptance of health related data being consumed via its devices, in this case the iWatch.

1. Thomas Beck pointed out above that the iWatch is a "Fashion Device." This is absolutely true. BUT more importantly it is a multipurpose device. Unless I have an immediate medical need, I am far less likely to wear a purpose built medical device. However, if my device serves many purposes, including the ability to use it for some health/ medical related applications, the more value it brings me as a consumer. The more cool things I think it can do for me, the more likely I am to aspire to get it and wear it everyday.

1. Having launched over 150 consumer electronic products myself, I truly believe that "as we drive market penetration, we also drive consumer sophistication." Apple knows this better than anybody. The iWatch requires users to master a few new UX and new features. Also, you can only mention so many features in your adds and training. So, you first go-to-market with highly attractive, but simple and easy to use features & services (Aka the base line). Once consumers have mastered the use of the iWatch, you can add more functionality such as medical related features.

1. In my opinion the medical staff is on board at Apple to ensure that they avoid the potential regulatory pitfalls of medical devices, while maximizing the enablement of such services for a future release. Knowing how Apple works, it is very likely that the medical staff helped in the design of the existing HW. After all, it is much easier to have an existing customer base upgrade their SW vs the HW. This would make a future health/ medical services a simple OS release.

In conclusion, Apple did not have to get into the medical device business on day one. Job #1 is getting the iWatch into as many wrists as possible & make consumers aware of what it does beyond telling time. Once it does this, developers can take the risk and create the incentive for Apple to make it more and more a true medical device. Once this is achieved, Apple can then leverage it to create a medical profile into iCloud and have it link to physicians.