Final Guidance: Premarket Submissions for Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use

U.S. Food and Drug Administration sent this bulletin at 12/22/2021 09:18 AM EST

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FDA - Center for Devices and Radiological Health

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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. 

Read the Guidance

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.