Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.
Kadakia K, Bikdeli B, Gupta A, Dhruva S, Ross J, Krumholz H. Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals Of Internal Medicine 2024 PMID: 39556835, DOI: 10.7326/annals-24-00089.Peer-Reviewed Original ResearchMedical device regulationDetect adverse eventsDevice regulationInferior vena cavaPatient safetyFood and Drug AdministrationDevice safetyOutcome definitionsStudy protocolPatient deathClinical study protocolAdverse eventsProfessional societiesCourt documentsClinical practiceRegulatory reformCliniciansInferior vena cava perforationDevice labelingPrevention of pulmonary embolismPublished literaturePublic recordsInaccurate informationCelect IVC filtersMedical devicesModernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
Kadakia K, Rathi V, Dhruva S, Ross J, Krumholz H. Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process. Annals Of Internal Medicine 2024, 177: 1558-1565. PMID: 39374526, DOI: 10.7326/annals-24-00728.Peer-Reviewed Original Research