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Zdrowie i gospodarka · 27.07.2018

Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Peripheral Vascular Atherectomy Devices--Premarket Notification [510(k)] Submissions." This draft guidance provides recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. This draft guidance is not final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →