Japanese guidance for ventricular assist devices/total artificial hearts

Takashi Yamane, Shunei Kyo, Hikaru Matsuda, Yusuke Abe, Kou Imachi, Toru Masuzawa, Takeshi Nakatani, Kazuhiro Sase, Koichi Tabayashi, Setsuo Takatani, Eisuke Tatsumi, Mitsuo Umezu, Toshie Tsuchiya

Research output: Contribution to journalShort surveypeer-review

12 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)699-702
Number of pages4
JournalArtificial Organs
Volume34
Issue number9
DOIs
Publication statusPublished - 2010 Sep

Keywords

  • Evaluation criteria
  • Guidance
  • Total artificial heart
  • Ventricular assist device

ASJC Scopus subject areas

  • Bioengineering
  • Medicine (miscellaneous)
  • Biomaterials
  • Biomedical Engineering

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