Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarketPostmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration
Rathi VK, Ross JS, Samuel AM, Mehra S. Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration. Otolaryngology 2015, 153: 400-408. PMID: 26044785, DOI: 10.1177/0194599815587508.Peer-Reviewed Original ResearchConceptsClinical dataUS FoodDrug AdministrationPMA pathwayRetrospective cohort studyAdditional clinical dataPremarket approval pathwaySignificant clinical implicationsCohort studyHigh-risk medical devicesMedian numberClinical implicationsMarketing clearanceLife spanAdministrationSubstantial numberPMA applicationApproval pathwaySupplementsFDATherapeutic devicesPathway