Updated Final Guidance: Peripheral Vascular Atherectomy Devices

The FDA provides updated recommendations in the recently published final guidance.

If your email program has trouble displaying this email, view as a webpage. FDA Issues an Updated Final Guidance on Peripheral Vascular Atherectomy Devices Today, the U.S. Food and Drug Administration (FDA) updated this final guidance: Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions. This guidance provides device manufacturers with recommendations for 510(k) submissions for peripheral vascular atherectomy devices. Read the Guidance Facts about the final guidance The final guidance was previously issued on February 13, 2020. With this update, the guidance aligns with current review practices of similar cardiovascular devices. The guidance includes updates from the draft guidance Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Clarification of pyrogenicity language Addition to the stimulated-use testing recommendations Addition of a particulate evaluation section Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.

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