Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications." This draft guidance document describes FDA's recommendations about investigational device exemption and premarket approval applications for heart valves. This draft guidance document is not final, nor is it in effect at this time.