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...

Descripción completa

Guardado en:
Detalles Bibliográficos
Publicado en:JAMA
Autores principales: Zheng, Sarah Y., Dhruva, Sanket S., Redberg, Rita F.
Formato: Artigo
Lenguaje:Inglês
Publicado: American Medical Association 2017
Materias:
Original Investigation
Acceso en línea: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
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!

Ejemplares similares