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FDA Issues Final Guidance for Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use
Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions. These devices are designed to deliver irrigation fluid to the surgical site during arthroscopic procedures.
Facts about the final guidance
This final guidance:
- Outlines device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use.
- Clarifies terminology used to describe these devices.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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