title: Japanese guidance for ventricular assist devices/total artificial hearts.
abstract: To facilitate research and development (R&D) and to expedite the review processes of medical devices, the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) founded a joint committee to establish guidance for newly emerging technology. From 2005 to 2007, two working groups held discussions on ventricular assist devices and total artificial hearts, including out-of-hospital programs, based on previous guidance documents and standards. Based on this discussion, the METI published the R&D Guidelines for innovative artificial hearts in 2007, and in 2008 the MHLW published a Notification by Director regarding the evaluation criteria for emerging technology.
authors.affiliation: National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan. yamane.t@aist.go.jp
authors.forename: Takashi
authors.initials: T
authors.lastname: Yamane
authors.forename: Shunei
authors.initials: S
authors.lastname: Kyo
authors.forename: Hikaru
authors.initials: H
authors.lastname: Matsuda
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Abe
authors.forename: Kou
authors.initials: K
authors.lastname: Imachi
authors.forename: Toru
authors.initials: T
authors.lastname: Masuzawa
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nakatani
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Sase
authors.forename: Koichi
authors.initials: K
authors.lastname: Tabayashi
authors.forename: Setsuo
authors.initials: S
authors.lastname: Takatani
authors.forename: Eisuke
authors.initials: E
authors.lastname: Tatsumi
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Umezu
authors.forename: Toshie
authors.initials: T
authors.lastname: Tsuchiya
mesh_terms: D000818:Animals; D006801:Humans; D003257:Consumer Product Safety; D018795:Device Approval / Q000592:standards; D006354:Heart, Artificial / Q000009:adverse effects / Q000592:standards; D006353:Heart-Assist Devices / Q000009:adverse effects / Q000592:standards; D007564:Japan; D011474:Prosthesis Design; D018570:Risk Assessment