The Food and Drug Administration on Thursday published a list of reusable medical devices that hold the greatest risk of infection transmission or poor performance if not appropriately reprocessed, reports Regulatory Focus.
The agency will now require devicemakers to submit validated instructions for use — along with validation data regarding the cleaning, disinfection and sterilization of the device — as part of the premarket notification submission process, according to the report.
The list — an FDA requirement designated by the 21st Century Cures Act — features numerous types of bronchoscopes and endoscopes, among other devices.
To view the list of devices, click here.
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