New England Journal of Medicine · 2011 · 144 citations · 1 references
PharmacyHealth LawHealth PolicyDrug Approval ProcessesHealth Technology AssessmentRegulatory ScienceDevice RegulationDrug ApprovalMedical Device EvaluationMedical Device Quality AssuranceMedical Device RegistrationMedical Device SafetyBalancingMarket AuthorizationMarket Authorization PathwaysMedical Device AuthorizationMedical Device IndicationsPre-market Device ApprovalSubstantial Equivalence DeterminationSubstantial Equivalence Review
The FDA approval system cannot assure the safety and effectiveness of increasingly complex medical devices. The Institute of Medicine has recommended eliminating a process that permits approval of a device based on its “substantial equivalence” to an existing device.
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