510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs
FDA is requiring that manufacturers of certain reusable medical devices include instructions for use that have been validated, along with validation data related to cleaning, disinfection and sterilization in their 510(k)s. Recently published on the Federal Register, the document, “Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications”, contains a list of devices, which include certain bronchoscopes and accessories; ear, nose and throat endoscopes and accessories; duodenoscopes and other gastroenterology and urology endoscopes that have elevator channels; neurological endoscopes; arthroscopes; laparoscopes; and water-based heater-cooler systems used in operating rooms. The document also names design features that could make it more difficult to reprocess instruments and accessories, such as lumens, hinges, shafts with lumens, crevices, ridges or grooves, porous materials, internal movable device components and features that may entrap debris.
“FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s.” – FDA
The actions are effective August 8.
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