How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
Samuel AM, Rathi VK, Grauer JN, Ross JS. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval? Clinical Orthopaedics And Related Research® 2015, 474: 1053-1068. PMID: 26584802, PMCID: PMC4773325, DOI: 10.1007/s11999-015-4634-x.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDatabases, FactualDevice ApprovalEquipment DesignHumansMedical Device RecallsOrthopedic EquipmentOrthopedic ProceduresPatient SafetyProduct Surveillance, PostmarketingRetrospective StudiesRisk FactorsSafety-Based Medical Device WithdrawalsTime FactorsUnited StatesUnited States Food and Drug AdministrationCharacteristics 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 devicesPathwayPost-market clinical research conducted by medical device manufacturers: a cross-sectional survey
Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Medical Devices Evidence And Research 2015, Volume 8: 241-249. PMID: 26060416, PMCID: PMC4454210, DOI: 10.2147/mder.s82964.Peer-Reviewed Original Research