As Apple AAPL +2.96% advances the medical promise of its watch and smartphones, it has also made clear that it’s foremost aim is to steer clear of Food and Drug Administration regulation. Many assert that this imperative has rendered the health features in its sensor-laden watch underwhelming. Apple didn’t want to cross the lines that would class its new watch as a “medical device” in the eyes of regulators.
Those lines are increasingly murky. FDA put out guidance earlier this year meant to set a boundary between digital tech not subject to its oversight, and the products that regulators want to review. FDA billed the document as an act of “de-regulation” because agency staff asserted whole categories of products that they didn’t seek to actively supervise. But the stuff FDA excluded was pedestrian. The scheme they reserved for the vast rest of the digital health tools wasn’t well articulated.
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