The evolution of medical device safety has been in motion since 1968 when the U.S. Food and Drug Administration (FDA) first became responsible for medical device regulation. In the last three decades, technology-powered medical devices have exploded into clinical practice with a persistent need to evolve and become safer for a more diverse and less technically sophisticated range of users. As medical device technology matures and the technology becomes more capable, it also becomes more complex, requiring safety mechanisms that do more. Safety features iteratively improve, as implementations become more nuanced, sophisticated, and context-aware, but the underlying safety principles being applied remain surprisingly constant.
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