Medical device innovation in America: tensions between food and drug law and patent law.

Authors :: Lewin, Adam
Source :: Harvard Journal of Law & Technology. Fall, 2012, Vol. 26 Issue 1, p403, 25 p.
Publication Year :: 2012
Abstract: TABLE OF CONTENTS I. INTRODUCTION II. FDA's Medical DEVICE REGULATORY FRAMEWORK A. The Medical Device Amendments of 1976 B. Three Classes, Three Types of Oversight. C. The 510(k) Scheme 1. [...]

Subjects :: Patent law -- Evaluation
Medical test kit industry -- Laws, regulations and rules
Medical equipment and supplies industry -- Laws, regulations and rules
Food law -- Evaluation
United States. Food and Drug Administration -- Evaluation
Government regulation

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