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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USA: Summary of New 510(K) Guidance Documents Published in the second half of 2020

• 2021-02-22 02:47:33

Recently the FDA has introduced 5 types of medical devices which can be submitted for evaluation using the latest Safety and Performance Based Pathway. With that, official guidance documents on performance criteria for these devices finally have been issued.

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