FDA Says Consider Device Context, Not Just Intended Use
Every medical device has an intended use but it’s the context that also must be considered when thinking about risk. “You can only understand the safety and effectiveness of the product that you sell…by considering how it interacts with the system implied by its intended use,” said Alfred Taylor, Jr., associate director of engineering and quality management at CDRH’s Office of Science and Engineering Laboratories, at last month’s MedTech Intelligence conference on risk management and risk acceptability. Taylor added that while this concept isn’t written into regulation, “to me, it’s just common sense.”
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