USA: Final Premarket Notification (510(k)) Submissions Guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheter – June/July 2023

• 2023-06-28 07:24:11

The Food and Drug Administration (FDA) has recently released guidance aimed at streamlining the premarket notification (510(k)) submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. This guidance provides manufacturers and FDA staff with comprehensive recommendations to ensure regulatory compliance and enhance the safety and effectiveness of these medical devices

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