title: Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation.
abstract: Our aim was to conduct a scoping review of the regulations for hemodialyzers in the safety evaluation in Japan and the United States, and to evaluate the criteria for premarketing clinical trials and postmarketing safety reports to inform the development of a sophisticated premarketing evaluation in Japan. Regulations for approval of hemodialyzers were identified from the databases of the Ministry of Health, Labor and Welfare in Japan and the Federal Drug Agency (FDA) in the United States (US). The criteria for premarket clinical trials and postmarketing safety reports were evaluated for both countries. Standards in Japan required evaluation of blood compatibility and reporting of acute adverse effects by a premarketing clinical trial in 6 of 86 applications with semipermeable membrane materials deemed to be different to those of previously approved devices from 1983 to 31 August 2015. By comparison, the clinical trial was required in one of 545 approvals in the US from 1976 to 29 January 2016, but blood compatibility was not the point. All postmarketing adverse effects identified in Japan were included in the set of 'warnings'. The more stringent requirements for evaluation of blood compatibility and acute adverse effects in Japan seemed to be related to differences in the history of quality management systems for medical devices between the two countries. This study revealed that there were differences between Japan and the US in requiring the premarketing clinical trials for the hemodialyzers. Our findings could be useful for constructing sophisticated premarketing safety evaluation.
authors.affiliation: Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, Tokyo, Japan.
authors.forename: Masami
authors.initials: M
authors.lastname: Saito
authors.affiliation: Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, Tokyo, Japan. iwasaki@waseda.jp.|Faculty of Science and Engineering, Waseda University, Tokyo, Japan. iwasaki@waseda.jp.
authors.forename: Kiyotaka
authors.identifier: http://orcid.org/0000-0002-3994-5509
authors.initials: K
authors.lastname: Iwasaki
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D007564:Japan; D007688:Kidneys, Artificial / Q000592:standards*; D011358:Product Surveillance, Postmarketing; D012449:Safety; D014481:United States
keywords: Dialysis; Postmarketing evaluation; Premarketing evaluation; Regulatory science