Zdrowie i gospodarka · 13.07.2020

Select Updates for Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Select Updates for Peripheral Vascular Atherectomy Devices--Premarket Notification (510(k)) Submissions." FDA has developed this draft guidance to propose select updates to certain sections of the existing FDA guidance document "Peripheral Vascular Atherectomy Devices--Premarket Notification (510(k)) Submissions." This draft guidance is not final nor is it in effect at this time.