Bringing medical devices to market / Charlene Cho, editor.
2021
Items
Details
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
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
Print version: Bringing medical devices to market. Chicago, Illinois: American Bar Association, Health Law Section, [2021]
Linked Resources
Access via CalNet ID
Language
English
ISBN
9781641059718 (electronic book)
1641059710 (electronic book)
9781641059701
1641059702
1641059710 (electronic book)
9781641059701
1641059702
Record Appears in
Monographs & Serials
Electronic Resources
Electronic Resources