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

Details

Subject(s)
Editor
Sponsoring body
Library of Congress genre
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.
ISBN
  • 9781641059701
  • 1641059702
LCCN
2021042501
OCLC
1267411885
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