Put in perspective: Can you buy a car in Europe and bring it to the USA? Yes! BUT you have to federalize the car, meaning following all applicable rules and regulations that will apply to such a vehicle. Moving into the " interpretation of the FDA regulations AND industry applicable standards such as IEEE, ISPE, and hundreds more that Samsung must have to comply with to marketing their "devices" in every country...in this scenario, a wearable with a medical device capability. FDA 21 CFR Part 820 is the regulation that applies here, as this device will be capable to behave alike a medical device to determine patients (users) monitoring a possible "medical condition" as such. Manufacturer is responsible for compliance with said regulations IF the manufacturer wants to marketing their device for its intended use. For the record, the US FOOD AND DRUG ADMINISTRATION is a quasi-judiciary entity with full legal powers to enforce their laws and regulations. It is a Regutory Entity with so much legal power to put any company into a non-compliance status and,in worst case scenario, submit criminal charges in a Court of Law to enforce their mandate. How do I know? 20 years as a Quality&Compliance Engineer playing Perry Mason to assist medical devices and pharmaceutical companies on the "how to be in fully compliance mode"...a very interesting job. Samsung knows the "how and what to do". It takes time and effort to do the things right. It is going to be ready when it has to be ready. Also, politics has nothing to do with this. Worst Case Scenario: they fast tracking the process, users will have a nice device replacing their medical device, a failure occured...and big trouble occurred. I have seen big issues that I can't talk about due to legal constraints...Just saying.
