Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011

This cross-sectional study provides a 5-year update on the status and availability of postmarket evidence for high-risk medical devices that received FDA premarket approval in 2010 and 2011.

Detalles Bibliográficos
Autores principales: Rathi, Vinay K., Krumholz, Harlan M., Masoudi, Frederick A., Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2020
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7455850/
https://www.ncbi.nlm.nih.gov/pubmed/32857145
http://dx.doi.org/10.1001/jamanetworkopen.2020.14496
Descripción
Sumario:This cross-sectional study provides a 5-year update on the status and availability of postmarket evidence for high-risk medical devices that received FDA premarket approval in 2010 and 2011.

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