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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, 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: 29 July 2021

Device-ive Maneuvers

Device-ive Maneuvers

FDA’s Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing

Chapter:
(p.470) Chapter Twenty-Five Device-ive Maneuvers
Source:
FDA in the Twenty-First Century
Author(s):

Elizabeth R. Pike

Kayte Spector-Bagdady

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0033

The past decade has seen the emergence of bifurcated direct-to-consumer genetic testing entities—entities that either sequence genomic material (producing a list of a person’s As, Ts, Cs, and Gs) or that interpret the genomic sequence to provide information about a person’s predisposition to disease. Unlike entities that directly sell only the sequences, entities that produce genomic information fall within FDA’s current interpretation of a “device” and challenge its ability to classify genomic information on the basis of perceived risk and apply standard risk mitigation strategies.

Keywords:   Direct-to-consumer, Genetic, Genomic, genomic information, device, risk

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