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Princeton University Library Catalog
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Bringing medical devices to market / Charlene Cho, editor.
Format
Book
Language
English
Published/Created
Chicago, Illinois: American Bar Association, Health Law Section, [2021]
©2021
Description
xxx, 389 pages : forms ; 23 cm
Availability
Copies in the Library
Location
Call Number
Status
Location Service
Notes
ReCAP - Remote Storage
KF3827.M4 B75 2021
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Details
Subject(s)
Medical instruments and apparatus
—
Law and legislation
—
United States
[Browse]
Medical technology
—
Law and legislation
—
United States
[Browse]
New products
—
Law and legislation
—
United States
[Browse]
Sponsoring body
American Bar Association. Health Law Section
[Browse]
Editor
Cho, Charlene
[Browse]
Library of Congress genre(s)
Legal forms
[Browse]
Summary note
"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"-- Provided by publisher.
Bibliographic references
Includes bibliographical references and index.
Contents
FDA premarket requirements / Vernessa T. Pollard and Anisa Mohanty
FDA regulation of digital health care products / Jeffrey N. Gibbs and Allyson B. Mullen
Data, clinical trials, and good clinical practices / Gerard Prud'homme, Kristen Zielinski Duggan, Megana Sankaran
Intellectual property protections for medical devices / Ed Buthusiem, Jeffrey Klenk, and Eric Carlson
Business arrangements and contractual agreements / David Hatch and Robert Miller
Postmarket requirements / Paul Gadiock and Jamie Ravitz
Compliance and enforcement / Paul Gadiock and Jamie Ravitz
Import/exports / Allison Fulton
Fraud and abuse laws / Charlene Cho and Jennifer Michael
Coverage, coding, and reimbursement for medical devices / Beth Halpern, with Mahmud Brifkani, Boyd Jackson, Soraya Keskey, and Maria Malas
AI--products liability / Terrence Dee.
Show 8 more Contents items
ISBN
9781641059701
1641059702
LCCN
2021042501
OCLC
1267411885
Statement on language in description
Princeton University Library aims to describe library materials in a manner that is respectful to the individuals and communities who create, use, and are represented in the collections we manage.
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