Japanese guidance for ventricular assist devices/total artificial hearts.
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.
Yamane
Takashi
T
National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan. yamane.t@aist.go.jp
Kyo
Shunei
S
Matsuda
Hikaru
H
Abe
Yusuke
Y
Imachi
Kou
K
Masuzawa
Toru
T
Nakatani
Takeshi
T
Sase
Kazuhiro
K
Tabayashi
Koichi
K
Takatani
Setsuo
S
Tatsumi
Eisuke
E
Umezu
Mitsuo
M
Tsuchiya
Toshie
T
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