LAUSR

Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad

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1 Published in 2019 at "Journal of Interventional Cardiac Electrophysiology"

DOI: 10.1007/s10840-019-00607-x

Abstract: Almost all electrophysiology (EP) devices need to obtain premarket approval before they can be commercially sold and available for use in the community. The US Food and Drug Administration (FDA) has different paths to market… read more here.

Keywords: regulatory approval; approval process; devices regulatory; electrophysiology devices ... See more keywords