JSPCCS-AHA Joint Symposium （I-AHAJS）
HBD-children in JAPAN

[I-AHAJS-Discussion02] Pre- and post-market clinical evaluation of pediatric medical devices, special focus on its feasibility
How to set and how to evaluate the primary and the secondary end point to develop these devices ?

杉山 央¹, 日本ライフライン株式会社, 方 眞美², Richard Ringel³, Frank Ing⁴, 富田 英⁵, 中村 泰子⁶ (1.東京女子医科大学心臓病センター 循環器小児科, 2.医薬品医療機器総合機構, 3.Johns Hopkins School of Medicine, 4.Los Angeles Children's Hospital, USA, 5.昭和大学病院　小児循環器・成人先天性心疾患センター, 6.医薬品医療機器総合機構)