Can I read FDA Guidance on Heart Valve Devices on EtoBox?

FDA Guidance on Heart Valve Devices by Bruno Costa is a document available to read on EtoBox.

What is FDA Guidance on Heart Valve Devices about?

This draft guidance provides recommendations for heart valve device manufacturers regarding Investigational Device Exemption (IDE) and Premarket Approval (PMA) applications. It outlines recommendations for preclinical testing, animal studies, clinical investigations, and PMA supplements. Key areas addressed include risk analysis, preclinical in vitro assessment of biocompatibility and durability, preclinical animal study design and reporting, clinical study design considerations like number of sites and sub

Author

Bruno Costa

Language

EN