Patient safety and efficacy as measured by clinical trials and regulatory policy.
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.
Harvey
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BE
U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Rockville, MD, USA.
Alpert
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S
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