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Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications

IMPORTANCE: Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed. OBJECT...

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Detalles Bibliográficos
Autores principales:	Lee, Samuel J., Cho, Lauren, Klang, Eyal, Wall, James, Rensi, Stefano, Glicksberg, Benjamin S.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Medical Association 2021
Materias:	Original Investigation
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220494/ https://www.ncbi.nlm.nih.gov/pubmed/34156454 http://dx.doi.org/10.1001/jamanetworkopen.2021.12562

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