Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--Premarket Notification (510(k)) Submissions." FDA has developed this guidance document to assist in the preparation of premarket notification submissions (510(k)) for arthroscopy pump tubing sets intended for multiple patient use. This guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. This guidance also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use.