title: New technology in electrophysiology: FDA process and perspective.
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.
authors.affiliation: 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.
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Selzman
authors.affiliation: 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.
authors.forename: Mark
authors.initials: M
authors.lastname: Fellman
authors.affiliation: 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.
authors.forename: Andrew
authors.initials: A
authors.lastname: Farb
authors.affiliation: 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.
authors.forename: Sergio
authors.initials: S
authors.lastname: de Del Castillo
authors.affiliation: 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.
authors.forename: Bram
authors.initials: B
authors.lastname: Zuckerman
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D022062:Electrophysiologic Techniques, Cardiac / Q000295:instrumentation* / Q000592:standards*; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
keywords: Food and Drug Administration (FDA); Innovation; Post market surveillance; Regulatory science