Jump to ContentJump to Main Navigation
FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
Users without a subscription are not able to see the full content.

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

Show Summary Details
Page of

PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 05 August 2021

Analog Agency in a Digital World

Analog Agency in a Digital World

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

Nathan Cortez

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0031

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

Columbia Scholarship Online requires a subscription or purchase to access the full text of books within the service. Public users can however freely search the site and view the abstracts and keywords for each book and chapter.

Please, subscribe or login to access full text content.

If you think you should have access to this title, please contact your librarian.

To troubleshoot, please check our FAQs, and if you can't find the answer there, please contact us .