Express preemption and premarket approval under the medical device amendments

被引：0

作者：

Scandaglia, GJ ^{[1
]}

Tully, TL ^{[1
]}

机构：

[1] Scandaglia & Ryan, Chicago, IL USA

来源：

FOOD AND DRUG LAW JOURNAL | 2004年 / 59卷 / 02期

关键词：

D O I：

暂无

中图分类号：

TS2 [食品工业];

学科分类号：

0832 ;

摘要：

引用

页码：245 / 264

页数：20

共 50 条

[1] THE STANDARD OF EVIDENCE REQUIRED FOR PREMARKET APPROVAL UNDER THE MEDICAL DEVICE AMENDMENTS OF 1976
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[3] FDA - MEDICAL DEVICE NEWS CORNER - OUTLINE FOR THE PREMARKET APPROVAL (PMA) APPLICATION
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[J]. JAMA NETWORK OPEN, 2023, 6 (04)
[5] Recovery and Preemption: The Collision of the Medicare Secondary Payer Act and the Medical Device Amendments
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[6] Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015
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[J]. JOURNAL OF THE AMERICAN COLLEGE OF RADIOLOGY, 2017, 14 (01) : 24 - 33
[7] LEGAL-ASPECTS OF PREMARKET APPROVAL OF MEDICAL DEVICES
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[J]. FOOD AND DRUG LAW JOURNAL, 1983, 38 (03): : 205 - 219
[8] Premarket approval and federal preemption of product liability claims in the wake of Medtronic, Inc v Lohr
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[9] LITIGATED CASES UNDER THE MEDICAL DEVICE AMENDMENTS OF 1976
HYMAN, PM
[J]. FOOD AND DRUG LAW JOURNAL, 1985, 40 (01): : 85 - 94
[10] Orthopaedic Device Approval Through the Premarket Approval Process A Financial Feasibility Analysis for a Single Center
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[J]. JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, 2017, 99 (06): : e26(1) - e26(8)

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