Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions Guidance for Industry and Food and Drug Administration Staff FEBRUARY 2020

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FDA Issues Final Guidance on Peripheral Vascular Atherectomy Devices

Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions.

Read the Guidance Facts about the final guidance The guidance applies to atherectomy devices used in the peripheral vasculature, which are classified by the FDA as class II devices. Atherectomy devices used in coronary vasculature are outside the scope of this final guidance. This guidance is intended to help manufacturers evaluate their device, enhance consistency of performance testing, and promote the safe use of these devices in clinical settings. Based on comments received on the draft guidance, the final guidance includes additional clarifying details, including examples, about content related to corrosion testing, bench testing, and software.  Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.