2024
Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024, 177: 1499-1508. PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketing
2020
Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Network Open 2020, 3: e2014496. PMID: 32857145, PMCID: PMC7455850, DOI: 10.1001/jamanetworkopen.2020.14496.Peer-Reviewed Original Research
2017
Clinical 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
2016
Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study
Phillips AT, Rathi VK, Ross JS. Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study. JAMA Internal Medicine 2016, 176: 551. PMID: 26902933, DOI: 10.1001/jamainternmed.2015.8590.Peer-Reviewed Original Research