Ensuring Medical Device Effectiveness and Safety: A Cross - National Comparison of Approaches to Regulation

摘要

This study was supported by funding from the Medical Device Initiative from the Pew Charitable Trusts. Dr. Kramer is the Lois Green Scholar at the Hebrew SeniorLife Institute for Aging Research, and is additionally supported by an award from the Harvard Catalyst Clinical and Translational Science Center, and a Paul B. Beeson Career Development Award (K23AG045963). Dr. Kesselheim is also supported by a career development award from the Agency for Healthcare Research & Quality (K08HS18465-01), a Greenwall Faculty Scholarship in Bioethics, and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research. Dr. Kramer reports serving as a consultant to Circulatory Systems Advisory Panel of the Food and Drug Administration. The authors would like to thank Yuka Sugamura of the Medical Device Safety Division at the Pharmaceuticals and Medical Devices Agency (Japan) as well as Liang Yan, head of Regulatory Affairs Division at the Shanghai Food and Drug Administration for their helpful conversations and insights.