Bringing medical devices to market / Charlene Cho, editor.
Cho, Charlene, editor.; American Bar Association. Health Law Section, sponsoring body.
2021
KF3827.M4 B75 2021 (Mapit)
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Title
Bringing medical devices to market / Charlene Cho, editor.
Added Author
Cho, Charlene, editor.
Added Corporate Author
American Bar Association. Health Law Section, sponsoring body.
Imprint
Chicago, Illinois: American Bar Association, Health Law Section, [2021]
Copyright
©2021
Description
xxx, 389 pages : forms ; 23 cm
Formatted Contents Note
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.
Summary
"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.
Bibliography, etc. Note
Includes bibliographical references and index.
Call Number
KF3827.M4 B75 2021
Language
English
ISBN
9781641059701
1641059702
Record Appears in
Monographs & Serials
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