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
2015
Post-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, 8: 241-249. PMID: 26060416, PMCID: PMC4454210, DOI: 10.2147/mder.s82964.Peer-Reviewed Original Research
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