This guidance was developed by the Infection Control Devices Branch, Division of General and Restorative Devices (DGRD), Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA).

FDA regulates the introduction of medical devices into interstate commerce. A person inicnding to market an endoscope washerldisinfector must submit to FDA, and have cleared, a premarket notification [510(k)] submission prior to its introduction into interstate commerce. Regulations governing the general content and format of 5 lo@) submissions are codified under 21 Code of Federal Regulations, Part 807. These and other regulatory requirements pertaining to the marketing of a new medical device are discussed in guidance documents available from the CDRH Division of Small Manufacturers Assistance (DSMA).

The intent of this guidance document is to provide 5100 applicants specific additional directions regarding information and data which should be submitted to FDA in a 510(k) submission for an endoscope washerldisinfector. In this guidance, the term washerldisinfector will be used to refer to endoscope washers, washerldisinfectors, and disinfectors.

A safe and effective system to disinfect endoscopes intended for use in other than normally sterile areas of the body is important in preventing nosocomial infections. Comprehensive, scientifically sound criteria for the evaluation of endoscope washers, washerldisinfectors, and disinfectors is essential to help ensure that these devices are safe and effective for their intended use when used according to their labeling. FDA recognizes the importance of providing applicants, and other interested parties, the agency's 510(k) submission criteria for endoscope washers, washerldisinfectors, and disinfectors in order to facilitate assembly of necessary data, to maintain consistency of review, and to provide for a more efficient regulatory process.

The document expresses FDA's recommendations as of the date noted on the cover page. There is ongoing research and debate with regard to endoscope design and test methods. Despite this state of flux, FDA finds it necessary at this time to document its 5 1 0 0 submission criteria in order to'expedite the availability of safe and effective washerldisinfectors. FDA expects that this document will stimulate andlor accelerate development of test methods and specific validation procedures by the scientific community and regulated industry. The document is not static but will be periodically revised to keep it current with state of the art developments in this area. Comments on the document are welcome and should be sent to the address noted on page 17.