Bringing medical devices to market / Charlene Cho, editor.
2021
Items
Details
Title
Bringing medical devices to market / Charlene Cho, editor.
Added Author
Added Corporate Author
Imprint
Chicago, Illinois: American Bar Association, Health Law Section, [2021]
Copyright
©2021
Description
1 online resource (xxx, 389 pages) : forms
Series
LexisNexis digital library.
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.
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.
Source of Description
Print version record.
Location
www
Available in Other Form
Linked Resources
Language
English
ISBN
9781641059718 (electronic book)
1641059710 (electronic book)
9781641059701
1641059702
1641059710 (electronic book)
9781641059701
1641059702
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