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Journal of Interventional Cardiac Electrophysiology

Erschienen in:

16.08.2019 | REVIEW

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

verfasst von: Kimberly A. Selzman, Hetal Patel, Kenneth Cavanaugh

Erschienen in: Journal of Interventional Cardiac Electrophysiology | Ausgabe 2/2019

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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 approval depending on the intended use and the associated risks of the device. The European Union and Japan have device approval processes that have many similarities as well as differences to the US regulatory system. This paper describes some of the history and background of the US device approval process with an emphasis on EP devices. It provides an overview of the different regulatory pathways in the USA that are currently being utilized and contrasts them to the procedures often used in the European Union and in Japan. It also touches on the impact of the twenty-first Century Cures Act and how the balance between premarket and postmarket regulatory oversight is continually being examined and refined.

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Titel: Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad
verfasst von: Kimberly A. Selzman
Hetal Patel
Kenneth Cavanaugh
Publikationsdatum: 16.08.2019
Verlag: Springer US
Erschienen in: Journal of Interventional Cardiac Electrophysiology / Ausgabe 2/2019
Print ISSN: 1383-875X
Elektronische ISSN: 1572-8595
DOI: https://doi.org/10.1007/s10840-019-00607-x

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