Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration

Christopher G Scully; Shawn Forrest; Loriano Galeotti; Suzanne B Schwartz; David G Strauss

doi:10.1016/j.annemergmed.2014.07.008

Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration

Ann Emerg Med. 2015 Apr;65(4):400-3. doi: 10.1016/j.annemergmed.2014.07.008. Epub 2014 Aug 13.

Authors

Christopher G Scully¹, Shawn Forrest², Loriano Galeotti¹, Suzanne B Schwartz³, David G Strauss⁴

Affiliations

¹ Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
² Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
³ Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
⁴ Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD. Electronic address: david.strauss@fda.hhs.gov.

PMID: 25128009
DOI: 10.1016/j.annemergmed.2014.07.008

Abstract

The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients.

Published by Elsevier Inc.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Biomedical Research / methods
Emergency Medical Services* / methods
Equipment and Supplies / adverse effects
Equipment and Supplies / standards*
Government Regulation*
Humans
Monitoring, Physiologic / instrumentation
United States
United States Food and Drug Administration / organization & administration*