2017
US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016
Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST. US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016. Otolaryngology 2017, 157: 608-617. PMID: 28786317, DOI: 10.1177/0194599817721689.Peer-Reviewed Original ResearchConceptsPremarket evidenceClinical evidenceClinical performance dataUS FoodAvailable FDA documentsFDA documentsEvidence of safetyDrug Administration clearanceOne-quarterNonclinical evidenceClinical practiceDrug AdministrationFDA clearanceOne-thirdTwo-thirdsClearanceFDATherapeutic devicesEvidenceSafetyOtolaryngologistsMajorityOtologicClinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005‐2014. Otolaryngology 2017, 156: 683-692. PMID: 28116974, DOI: 10.1177/0194599816689666.Peer-Reviewed Original ResearchConceptsPivotal studiesOriginal indicationPrimary endpointClinical evidenceDrug indicationsSupplemental indicationsUS FoodFDA approvalAvailable FDA documentsDouble-blinded studyDrug Administration approvalInformed treatment decisionsPivotal clinical studiesPremarket evidenceOtolaryngologic diseaseMedian enrollmentSurrogate markerAdministration approvalClinical studiesTreatment decisionsMost indicationsDrug AdministrationInitial approvalMultidisciplinary teamPrescription drugsClinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014. Otolaryngology 2017, 156: 285-288. PMID: 28093943, DOI: 10.1177/0194599816684094.Peer-Reviewed Original ResearchConceptsPostapproval studiesPivotal studiesUS FoodPrimary effectiveness end pointAvailable FDA documentsEffectiveness end pointPivotal clinical studiesBenefit-risk assessmentCross-sectional analysisPremarket evidenceMedian durationClinical evidenceDrug Administration premarket approvalsOtolaryngologic diseaseMedian enrollmentClinical studiesHigh-risk medical devicesDrug AdministrationEnd pointHigh-risk devicesFDA documentsOne-thirdTwo-thirdsPremarket approvalFDA
2015
Postmarket 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