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The Vitals

FDA Lists Reusable Medical Devices Needing More Data In 510(k)s

July 11, 2017
FDA recently published a list of reusable devices for which extra instructions and data on how to clean, disinfect and sterilize them must be included in 510(k) submissions in order for the devices to be deemed substantially equivalent to marketed devices, as required by the 21st Century Cures Act. As devices become more complex, additional steps must be taken to assure their safety, FDA says. “Additionally, there has been an evolution towards more complex reusable medical device designs that are...


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