Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices

Sanket S Dhruva; Carolyn M Mazure; Joseph S Ross; Rita F Redberg

doi:10.1001/jamainternmed.2017.3148

Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices

JAMA Intern Med. 2017 Sep 1;177(9):1390-1391. doi: 10.1001/jamainternmed.2017.3148.

Authors

Sanket S Dhruva^{1

2

3}, Carolyn M Mazure^{4

5}, Joseph S Ross^{1

6

7

8

9}, Rita F Redberg^{10

11

12}

Affiliations

¹ Robert Wood Johnson Foundation Clinical Scholars Program, Yale University School of Medicine, New Haven, Connecticut.
² Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
³ Veterans Affairs Connecticut Healthcare System, West Haven.
⁴ Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.
⁵ Women's Health Research at Yale, Yale School of Medicine, New Haven, Connecticut.
⁶ Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
⁷ Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut.
⁸ Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
⁹ Associate Editor.
¹⁰ Division of Cardiology, Department of Medicine, University of California-San Francisco School of Medicine, San Francisco, California.
¹¹ Philip R. Lee Institute for Health Policy Studies, University of California-San Francisco School of Medicine, San Francisco, California.
¹² Editor.

Abstract

This analysis characterizes the studies used to support US Food & Drug Administration 2015 premarket approval of devices, particularly findings of device safety and effectiveness for women, the elderly, and minorities.

Publication types

Letter

MeSH terms

Demography / statistics & numerical data*
Device Approval / legislation & jurisprudence*
Humans
United States
United States Food and Drug Administration / statistics & numerical data*

Grants and funding

UL1 TR001863/TR/NCATS NIH HHS/United States