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Regulating Posttrial Access to In-Dwelling Class III Neural Devices
Wright M, Fins J. Regulating Posttrial Access to In-Dwelling Class III Neural Devices. 2022, 256-267. DOI: 10.1017/9781108975452.020.Peer-Reviewed Original ResearchMedical device regulationRegulatory lawsDevice regulationCambridge CorePosttrial accessMedical devicesRegulatory concernsOpen AccessPatient privacyRegulationPublic healthMedical providersLawInnovative productsEUBookConcernsControversiesPrivacyPolicymakersAccessUSStakeholdersCambridgeMultidisciplinary evaluation
2012
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Fins J, Dorfman G, Pancrazio J. Challenges to deep brain stimulation: a pragmatic response to ethical, fiscal, and regulatory concerns. Annals Of The New York Academy Of Sciences 2012, 1265: 80-90. PMID: 22823486, PMCID: PMC4030320, DOI: 10.1111/j.1749-6632.2012.06598.x.Peer-Reviewed Original ResearchConceptsIntellectual property exchangePre-market approval processBayh-Dole ActIntellectual property interestsCommon-sense strategiesProperty interestsBayh-DoleRegulatory sphereProperty exchangeManagement of conflictCollege recommendationsApproval processRegulatory concernsPragmatic responseFunded researchPublic-private partnershipInformal mannerExemptionActReformRevisionConflictGovernmentInterest