• FDA Not Planning Regulatory Hurdles for Apple Watch



    With the U.S. Food and Drug Administration taking a closer look in recent years at mHealth-related apps and technologies, many wondered if and how the agency would react and respond to Apple Watch.

    With Apple's first-ever wearable set for release in just under a month, we finally got our answer this morning from the FDA. Bakul Patel, an FDA official focused on consumer-centric health products, expressed to Bloomberg the FDA's plan to be pretty hands-off with regard to regulations and Apple Watch.

    "We are taking a very light touch, an almost hands-off approach," Patel is quoted in the report. "If you have technology that's going to motivate a person to stay healthy, that's not something we want to be engaged in."

    Of course, it should come as little surprise that Apple Watch has provoked a critical eye from the FDA, which is primarily concerned with cracking down on tech and apps that make bold, unsubstantiated and potentially dangerous claims about treating or curing particular ailments.

    Apple Watch, thus far, has been postured as a health and wellness device that, while certainly contributing to better health through no shortage of monitoring capabilities, stops well short of making assertions about treating or curing health conditions or diseases.

    Source: Bloomberg
    This article was originally published in forum thread: FDA Not Planning Regulatory Hurdles for Apple Watch started by Michael Essany View original post
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