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Author Kahan, Jonathan S., author
Title Medical device development : regulation and law / Jonathan S. Kahan (partner, Hogan Lovells US, LLP)
Imprint [Needham, Massachusetts] : Barnett International, [2014]
book jacket
 Euro-Am Studies Lib  344.73041 K12 2014    DUE 08-28-24  -  30500101502048
Edition [Third edition]
Descript xx, 622 pages : illustrations ; 24 cm
text txt rdacontent
unmediated n rdamedia
volume nc rdacarrier
Note "A title of PAREXEL International Corporation."
Includes bibliographical references and index
The framework for regulation of medical devices -- The 510(k) premarket notification process -- Device modifications requiring a 510(k) notice -- FDA regulation of medical device software -- The investigational device exemption application : overview of the IDE process and humanitarian devices -- Medical device clinical studies -- The premarket approval application -- Review of a premarket approval application -- PMA supplements -- Medical device reclassification -- The regulation of in vitro diagnostics -- The quality system regulation -- Compliance -- Medical device exports and imports -- Product jurisdiction and the regulation of combination products -- Working well with FDA
Link Revision of: Kahan, Jonathan S. Medical device development. Needham, MA : PAREXEL, c2009 9781882615926 (OCoLC)432988124
Subject Medical instruments and apparatus -- Law and legislation -- United States
Medical instruments and apparatus -- Safety regulations -- United States
Medical instruments and apparatus -- Design and construction
Alt Author Parexel International Corporation, issuing body
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