title: An example of US Food and Drug Administration device regulation: medical devices indicated for use in acute ischemic stroke.
abstract: The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre- and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre- and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.
authors.affiliation: Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD, USA. carlos.pena@fda.hhs.gov
authors.forename: Carlos
authors.initials: C
authors.lastname: Peña
authors.forename: Khan
authors.initials: K
authors.lastname: Li
authors.forename: Richard
authors.initials: R
authors.lastname: Felten
authors.forename: Neil
authors.initials: N
authors.lastname: Ogden
authors.forename: Mark
authors.initials: M
authors.lastname: Melkerson
mesh_terms: D000208:Acute Disease; D000818:Animals; D002545:Brain Ischemia / Q000453:epidemiology / Q000628:therapy*; D018795:Device Approval; D006801:Humans; D020521:Stroke / Q000453:epidemiology / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends