https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-peripheral-vascular-atherectomy-devices-premarket-notification-510k-submissions?utm_campaign=2020-07-10%20Draft%20Guidance%20Peripheral%20Vascular%20Atherectomy%20Devices&utm_medium=email&utm_source=Eloqua

FDA Issues Draft Guidance on Select Updates for Peripheral Vascular Atherectomy Devices

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions. In this draft guidance, the FDA proposes to update a subset of the technical bench testing recommendations in the atherectomy final guidance document. This guidance is not for implementation at this time.

Read the Draft Guidance Facts about the draft guidance  This draft guidance, when finalized, will align with the review practices of similar cardiovascular devices. Proposed changes and updates include:   Clarification of pyrogenicity language  Additions to the simulated-use testing recommendations  Addition of a particulate evaluation section Submit comments on this draft guidance  This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2018-D-2494. Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.