의료법학 (The Korean Society of Law and Medicine)
- 제15권2호
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- Pages.63-89
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- 2014
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- 1229-8069(pISSN)
의료기기의 결함으로 인한 손해배상책임과 미국 연방법 우선 적용 이론에 관하여
The Liability for Unsafe Medical Product and The Preemption Clause of Medical Device Act
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김장한
(울산대학교 의과대학 인문사회의학교실)
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Kim, Jang Han
(University of Ulsan College of Medicine Department of Medical Humanities and Social Science)
- 투고 : 2014.10.15
- 심사 : 2014.12.14
- 발행 : 2014.12.31
초록
In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C.