在完成eSTAR的过程中,提交者可以将附件添加为非结构化数据,包括但不限于提交者认为与设备审查相关的文档、PDF、图像和视频。此外,eSTAR将提示您提供所需的任何文档。 原文可点击一下链接 ↓ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-510...
so you would be foolish to ignore them. However, be prepared to substantiate with a scientifically justified alternative for any deviations from the published guidance or else you will receive a request for Additional Information (AI) during the review of the 510k. In fact, during the RTA check...
原文见FDA指南文件https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled 需要了解的是该指南的适用范围仅限于采用基于微生物灭活的行业最终灭菌工艺灭菌的无菌类器械的510(k)审查。FDA认为目前生产过...
The MosaiQ AiPlex CD solution addresses this need by enabling early disease detection and facilitating more targeted and effective treatments, offering much-needed relief to patients," said Manuel O. Méndez, CEO of AliveDx. "Today's submission brings us...
FDA使用基于安全和性能的途径对510(k)做出MDUFA决策的计划是90个FDA日。有关更多信息,请参阅510(k)提交过程(https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process),该过程描述了FDA收到提交后的审查过程。 近...
在不久的将来,正式版指南的出台,将更加有利于医疗器械制造商在510(k)申请过程中更加有针对性、有效地开展注册工作。 原文链接:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-selecting-predicate-device-support-premarket-notification-510k-submission...
De Novo Draft Guidance: FDA Review With No 510(k) SubmissionSue Darcey
FDA是对于非豁免的Class I 和II类产品都是提交510k 申请的,510k 还有另一名字哦,叫Pre-market Notification(既PMN,上市前通知),那对于豁免的510k的产品都是直接进行登记列名就可以了。那大部分的Class III 类产品认证途径是Pre-market approval (既PMA,上市前批准)。
Preliminary Guidance for Building a Successful FDA 510(k) Submission FDA clearance is critical to your market success and Intertek will help you navigate the 510(k) submission process quickly and efficiently. Missing information and deficiencies in your 510(k) submission can lead to failure and ...
Abbreviated 510k Clearance Process This submission type relies on the use of summary reports which demonstrate your use of special controls or Declarations of Conformity to recognized standards and guidance documents. Your medical device or IVD might qualify for this type of submission submission if: ...