Details

Subject(s)

• Medical instruments and apparatus—Law and legislation—United States [Browse]
• Medical technology—Law and legislation—United States [Browse]
• New products—Law and legislation—United States [Browse]

Editor

• Cho, Charlene [Browse]

Sponsoring body

• American Bar Association. Health Law Section [Browse]

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

Statement on language in description

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