Apple wants to certify the iWatch by the FDA

fda

The latest reports claim that the iWatch is up to awaiting FDA approval, US Food and Drug Administration, which is the North American body in charge of health surveillance.

This first generation of Apple's iWatch seeks certification before its fall release, according to the website laoyaoba. Citing internal sources, the site claims that Apple has already finalized the design and specifications of the watch, noting that the company is trying to source the device. certified as medical team.

It had already been news that Apple had met with the FDA in December to discuss a number of topics, with some analysts suggesting that Apple may be laying the groundwork for the use, with scientific rigor, of the iWatch. However, a note issued by the FDA noted that the meeting revolved around the guidance of mobile applications that could be implemented and thus ensure that the tech industry and regulators are aligned.

These apps could have focused on the iOS 8 Health app and the entire HealthKit, but the sensors that the iWatch could possess are unique and go beyond an application to monitoring sports or health. Remember that the iWatch would come with a series of advanced health sensors, including those that measure heart rate, blood pressure and blood glucose. Apple would also have developed a sensor that would analyze sweat, which would cover all the information needs of any iOS 8 health application.

While Apple hired a good number of specialists In fields such as blood glucose monitoring, it has been observed that these technologies cannot do this in the first generation iWatch, requiring a lengthy FDA approval process and complex hardware integration.

For the curious, the FDA is responsible for:

  • The protection of public health by ensuring that food is safe, healthy, sanitary and properly labeled; human and veterinary drugs and vaccines and other biological products and that devices medical for human use are safe and effective.
  • Protect the public from electronic product radiation.
  • Ensure that cosmetics and dietary supplements are safe and are properly labeled.
  • Regulation of tobacco products.
  • Promote the progress of public health, helping to accelerate the product innovations.
  • Help the public obtain the exact information they need to use the medications, devices and foods to improve your health.
FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other United States territories and possessions.

As we can see, iWatch regulation could pass through four of the six FDA targets.


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