Category: Clinical Trial

Grey literature and medical devices

Finally got my copy of this interesting book on grey literature, which has great impact on medical device regulatory compliance. One of the definitions of grey literature is: “Grey literature stands for manifold document types produced on all levels of government, academics, business and industry in print and electronic formats that are protected by intellectual […]

Análise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto risco (Portuguese only)

Análise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto risco. Conclusões:Considerando a amostra de indeferimentos de registro sanitário estudada, os achados sugerem uma heterogeneidade tanto na qualidade quanto no formato dos dados fornecidos em avaliações clínicas pelas empresas que submetem registros sanitários de dispositivos médicos, especialmente relacionado à natureza metodológica […]

CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation

Interesting findings – “results of the computer-simulated VICTRE trial are consistent with the comparative trial using human subjects and human image interpreters. While further research is needed to assess the generalizability of the findings, the work reported in this article provides evidence that state-of-the-art computational methods can lead to less burdensome regulatory evaluation approaches”. VICTRE: […]