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.
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 The guidance includes updates from the draft guidance Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: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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