New technology in electrophysiology: FDA process and perspective

Kimberly A Selzman; Mark Fellman; Andrew Farb; Sergio de Del Castillo; Bram Zuckerman

doi:10.1007/s10840-016-0127-4

New technology in electrophysiology: FDA process and perspective

J Interv Card Electrophysiol. 2016 Oct;47(1):11-18. doi: 10.1007/s10840-016-0127-4. Epub 2016 Mar 28.

Authors

Kimberly A Selzman¹, Mark Fellman², Andrew Farb², Sergio de Del Castillo², Bram Zuckerman²

Affiliations

¹ Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Implantable Electrophysiological Devices Branch, WO66, Silver Spring, MD, 20993, USA. kimberly.selzman@fda.hhs.gov.
² Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Implantable Electrophysiological Devices Branch, WO66, Silver Spring, MD, 20993, USA.

PMID: 27020440
DOI: 10.1007/s10840-016-0127-4

Abstract

The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.

Keywords: Food and Drug Administration (FDA); Innovation; Post market surveillance; Regulatory science.

Publication types

Review

MeSH terms

Device Approval / legislation & jurisprudence
Device Approval / standards*
Electrophysiologic Techniques, Cardiac / instrumentation*
Electrophysiologic Techniques, Cardiac / standards*
Guidelines as Topic
Product Surveillance, Postmarketing / standards*
Technology Assessment, Biomedical / legislation & jurisprudence
Technology Assessment, Biomedical / standards*
United States
United States Food and Drug Administration / standards*