title: Patient safety and efficacy as measured by clinical trials and regulatory policy.
abstract: Virtual Reality and other technological innovations in medicine provide new challenges to the regulatory framework of the premarket review process for medical devices. By reinventing the government-academia-industry partnership, clinical trial data necessary for a medical device to enter the market can be more efficiently obtained.
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Rockville, MD, USA.
authors.forename: B E
authors.initials: BE
authors.lastname: Harvey
authors.forename: S
authors.initials: S
authors.lastname: Alpert
mesh_terms: D002986:Clinical Trials as Topic; D020685:Colonoscopes; D018795:Device Approval; D006801:Humans; D007373:Interinstitutional Relations; D012107:Research Design; D014481:United States; D014584:User-Computer Interface