Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements

IMPORTANCE: 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. OBJECTIVE: To charac...

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Detalhes bibliográficos
Publicado no:JAMA
Main Authors: Zheng, Sarah Y., Dhruva, Sanket S., Redberg, Rita F.
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2017
Assuntos:
Original Investigation
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5817595/
https://ncbi.nlm.nih.gov/pubmed/28810022
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2017.9414
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