美国FDA医疗器械510(K)eSTAR正式实施 |
发布日期:2023-10-12 点击数:450 次 新闻来源:BIO23 |
eSTAR (electronic Submission Template And Resource): An electronic submission template14 built within a structured dynamic PDF that guides a user through construction of an eSubmission. eSTAR is the only type of electronic submission template that is currently available to facilitate the preparation of 510(k) submissions as eSubmissions. For simplicity, the electronic submission created with this electronic submission template is often referred to as an eSTAR. 即电子递交的模板与资料。美国FDA推出该模板的******主旨在于提高提交一致性和审查过程中的效率。
提交流程
现行eSTAR提交模板的结构
原文链接:Electronic Submission Template for Medical Device 510(k) Submissions | FDA https://www.fda.gov/media/152429/download |
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