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

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.

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Bibliographic Details
Published in:JAMA Intern Med
Main Authors: Dhruva, Sanket S., Mazure, Carolyn M., Ross, Joseph S., Redberg, Rita F.
Format: Artigo
Language:Inglês
Published: American Medical Association 2017
Subjects:
Research Letter
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC5818834/
https://ncbi.nlm.nih.gov/pubmed/28738116
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2017.3148
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