医学
环索奈德
哮喘
2019年冠状病毒病(COVID-19)
肺病
大流行
2019-20冠状病毒爆发
严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)
重症监护医学
内科学
疾病
吸入性皮质类固醇
传染病(医学专业)
病毒学
爆发
作者
Chao‐Hsien Chen,Cheng‐Yi Wang,Chih‐Cheng Lai
标识
DOI:10.1001/jamainternmed.2022.0207
摘要
Evaluation System for Health Technology) could help achieve these aims.We hope that this dialogue is not limited to a comparative exercise, but rather, that it marks a renewed effort toward global harmonization of regulatory standards for medical devices.For instance, the EU is finalizing updates to its medical device regulations, including key considerations for postmarket surveillance that could help inform similar policy reforms in the US.Consistency in regulatory expectations would avoid duplicative study designs by manufacturers.Likewise, the FDA Medical Device Epidemiology Network could help facilitate the coordination of the new Japanese registries for neuroendovascular devices, referred to by Dr Yamamoto and colleagues, with other global efforts-something the agency has previously done for orthopedic and vascular devices. 5Taken together, these perspectives reaffirm the need for medical device reform and the opportunities for shared regulatory learnings and global collaboration.
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