Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017

IMPORTANCE: The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices an...

ver descrição completa

Na minha lista:
Detalhes bibliográficos
Publicado no:JAMA Netw Open
Principais autores: Dubin, Jonathan R., Simon, Stephen D., Norrell, Kirsten, Perera, Jacob, Gowen, Jacob, Cil, Akin
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2021
Assuntos:
Original Investigation
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8103223/
https://ncbi.nlm.nih.gov/pubmed/33956132
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamanetworkopen.2021.7274
Tags: Adicionar Tag
Sem tags, seja o primeiro a adicionar uma tag!

Registros relacionados