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Medical device development : regulation and law / Jonathan S. Kahan (partner, Hogan Lovells US, LLP).
Holman Biotech Commons KF3827.M4 K34 2014
Available
Holman Biotech Commons KF3827.M4 K34 2014
Available
- Format:
- Book
- Author/Creator:
- Kahan, Jonathan S., author.
- Language:
- English
- Subjects (All):
- Medical instruments and apparatus--Law and legislation--United States.
- Medical instruments and apparatus.
- Medical instruments and apparatus--Safety regulations--United States.
- Medical instruments and apparatus--Safety regulations.
- Medical instruments and apparatus--Design and construction.
- Medical instruments and apparatus--Law and legislation.
- United States.
- Medical Device Legislation.
- Equipment Design--legislation & jurisprudence.
- Equipment and Supplies--legislation & jurisprudence.
- Equipment Safety--legislation & jurisprudence.
- Medical Subjects:
- Medical Device Legislation.
- Equipment Design--legislation & jurisprudence.
- Equipment and Supplies--legislation & jurisprudence.
- Equipment Safety--legislation & jurisprudence.
- United States.
- Physical Description:
- xx, 622 pages : illustrations ; 24 cm
- Edition:
- [Third edition].
- Place of Publication:
- [Needham, Massachusetts] : Barnett International, [2014]
- Contents:
- 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.
- Notes:
- "A title of PAREXEL International Corporation."
- Includes bibliographical references and index.
- Local Notes:
- Acquired for the Penn Libraries with assistance from the Albert E. Visk, W'28, Memorial Book Fund.
- Acquired for the Penn Libraries with assistance from the Rosengarten Family Fund.
- Other Edition:
- Revision of: 9781882615926 Kahan, Jonathan S. Needham, MA : PAREXEL, ©2009
- ISBN:
- 9780988314436
- 0988314436
- OCLC:
- 885359305
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