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

  • Kimberly A. SelzmanEmail author
  • Hetal Patel
  • Kenneth Cavanaugh


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.


FDA Regulation Premarket Device Approval De novo 



The authors would like to thank Dr. Madoka Murakami of the Japan Pharmaceuticals and Medical Devices Agency for helpful discussions regarding the Japanese regulatory system.

Compliance with ethical standards

The authors are employees of the Food and Drug Administration.

Conflict of interest

The authors have no other conflicts of interest.

The authors have no conflicts of interest besides what is stated above (employed by FDA).

Ethical approval

There was no Ethics Committee or IRB approval for this manuscript. There was no research involving humans or animals.

Informed consent



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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Center for Devices and Radiological HealthFood and Drug AdministrationSilver SpringUSA

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