2025
FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program
Kadakia K, Dhruva S, Ross J, Burke J, Johnston J, Ramachandran R, Krumholz H, Rathi V. FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program. JAMA Internal Medicine 2025, 185: 996-1004. PMID: 40587167, PMCID: PMC12210143, DOI: 10.1001/jamainternmed.2025.2235.Peer-Reviewed Original ResearchConceptsFood and Drug AdministrationFDA review timesFood and Drug Administration authorityFood and Drug Administration dataShort follow-up durationUS Food and Drug AdministrationFollow-up durationDevice programmingEffectiveness end pointCross-sectional studyHigh-risk devicesSurrogate measureTarget timeframePostmarketing studiesMain OutcomesEnd pointsPatient accessDrug AdministrationHigh riskClass IStudy characteristicsTherapeutic devicesClinical testingSurrogate measures of effectivenessMeasures of effectiveness
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
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