2025
Public Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed Tests
Kadakia K, Ross J, Ramachandran R. Public Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed Tests. JAMA Health Forum 2025, 6: e252233. PMID: 40540283, DOI: 10.1001/jamahealthforum.2025.2233.Peer-Reviewed Original ResearchConceptsLaboratory-developed testsFood and Drug AdministrationPublic health implicationsEastern District of TexasSupreme Court's recent decisionAssociation of Molecular PathologyCourt's recent decisionUS District CourtClinical evidence of safetyRegulate laboratory-developed testsFood and Drug Administration regulationsUS Food and Drug AdministrationPublic health concernPublic health emergencyMedical Devices AuthorityChevron doctrineDistrict CourtAgency interpretationsClinical careHealth technologiesImplementing statutesComplex molecular testsLegal challengesAmendment ActRegulatory remit
2024
Modernizing 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
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