title: Overview of the US FDA medical device approval process.
abstract: Increasing barriers to medical device innovation in the United States including constrained financial resources and rising research costs require that physicians take on greater involvement in medical device development, evaluation, and regulatory processes. Such involvement requires that physicians understand basic aspects of the regulatory process for medical devices and recognize the myriad opportunities for involvement in these activities.
authors.affiliation: New York Presbyterian Hospital, Columbia University Medical Center, 161 Fort Washington Avenue, Herbert Irving Pavilion 6th Floor, New York, NY, 10032, USA, as3066@columbia.edu.
authors.forename: Ashwani
authors.initials: A
authors.lastname: Sastry
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D005260:Female; D033161:Government Regulation; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence* / Q000592:standards; D010819:Physician's Role; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration