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

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ReCAP - Remote StorageKF3827.M4 B75 2021 Browse related items Request

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    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
    Statement on language in description
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