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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 03 July 2022

Analog Agency in a Digital World

Analog Agency in a Digital World

(p.438) Chapter Twenty-Three Analog Agency in a Digital World
FDA in the Twenty-First Century

Nathan Cortez

Columbia University Press

This chapter examines how the FDA has regulated computer hardware and software the last 40 years, finding several recurrent problems that neither the agency nor Congress has effectively addressed. The FDA needs updated statutory authority and increased in-house resources to modernize its approach to computerized devices, which now comprise over half of all medical devices on the market.

Keywords:   FDA, Devices, Software, Computers, Digital, mobile

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