Left to Their Own Devices Breakdowns in United States Medical Device Premarket Review 英文参考文献.docVIP

PolicyForum LefttoTheirOwnDevices:BreakdownsinUnitedStates MedicalDevicePremarketReview JonasZajacHines*,PeterLurie,EuniceYu,SidneyWolfe HealthResearchGroupatPublicCitizen,Washington,D.C.,UnitedStatesofAmerica Introduction approvals. Because of FDA policies pro- hibitingthereleaseofdataonunapproved products, we are unable to estimate the prevalence of these problems. Moreover, we do not evaluate each of the approxi- mately 3,000 applications approved or cleared by CDRH each year. Other aspectsofmedicaldeviceregulation,such as postmarketing surveillance, modifica- tions to already-approved d