FDA guidelines for endoscope reprocessing.

The Food and Drug Administration (FDA) relies on guidance documents, such as voluntary consensus standards and professional practice standards when reviewing the manufacturer's endoscope reprocessing instructions included in the instructions for use manual. The FDA does not perform endoscope reprocessing validation studies. The device manufacturer must certify that the reprocessing instructions included in the user manual have been or will be validated. This article discusses the regulatory review of gastrointestinal endoscopes and endoscope reprocessing instructions required prior to marketing.