Open AccessCharacteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
Author(s) -
Sarah Zheng,
Sanket S. Dhruva,
Rita F. Redberg
Publication year - 2017
Publication title -
jama
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.688
H-Index - 680
eISSN - 1538-3598
pISSN - 0098-7484
DOI - 10.1001/jama.2017.9414
Subject(s) - medicine , interquartile range , blinding , food and drug administration , clinical trial , trial registration , clinical research , surrogate endpoint , randomized controlled trial , randomization , environmental health
High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements.
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