![]() ![]() Instead, recognizing the meticulous work Apple had undertaken to validate the accuracy and reliability of the device, the agency shifted from a purely product-based regulatory focus to one that also considered the manufacturer’s overall work to validate a product. When Apple first approached the FDA, many observers were concerned that the agency would struggle to clear the Apple Watch as a medical device, fearing the FDA would insist on dissecting the device to fully understand its functionality. In 2022, Apple received a broader clearance to use the device in individuals with a known heart disorder, enabling wearers to manage their condition after they received a formal diagnosis. In 2018, when the FDA first cleared the watch as a medical device, it was for low-risk use in the detection of irregular heart rhythms such as atrial fibrillation in healthy individuals who had not already been diagnosed with a heart disorder. ![]() Take, for example, the heart monitor embedded in the Apple Watch. Simultaneously, it provides the FDA with the opportunity to incrementally modify its regulatory policies to best accommodate an innovation based on practical experience. This strategy enables innovators to enter the market more quickly than if they were to forge a brand-new path, and once marketed, developers can use the experience gained from real-world use to expand the applications of a new technology. The agency has established methods for evaluating existing technologies, and in almost all cases, new technologies can fit into one of these channels. The first lesson is the need to route a novel technology through a familiar regulatory pathway. Lesson 1: Begin With Established Processes Shared Decision Making and Communication. ![]() Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment. ![]()
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