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List of reusable devices subject to validation data requirements issued by FDA
6/9/2017

A list of reusable devices that will be required to have validated instructions for use and reprocessing validation data in 510(k) notifications starting in the next two months has been released by the FDA. The list, which is required under the 21st Century Cures Act, includes the devices that "currently have the greatest risk of infection transmission and inadequate performance if not adequately reprocessed," the agency said, adding that it believes most manufacturers of the listed devices are already working on validating their reprocessing information.

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