[웨비나, Emergo] US FDA Pre-Submissions

Emergo by UL 에서 미국 US FDA Pre-Submissions에 대한 웨비나를 진행한다. 최근에 FDA에서 변경된 Pre-submission에 대해 설명하고 각 제조업체에서 준비해야 되는 사항에 대해 설명할 것으로 예상된다.

 

▶ 일자: 2023년 11월 09일(목) 자정 (0시, CST 기준 오전 9시)

▶ 온라인으로 1시간동안 진행 예정

▶ 링크: U.S. FDA Pre-Submissions | Emergo by UL

U.S. FDA Pre-Submissions

 

[강의 주제설명]

The U.S. Food and Drug Administration (FDA) updated its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” on June 2, 2023. While the guidance identifies several types of Q-Submissions available where one can request feedback from the U.S. FDA, the current webinar will focus on Pre-Submissions. A Pre-Submission includes a request for feedback from the FDA as written feedback or as written feedback and a meeting before a pre-market submission. 

In this webinar, the presenter will help attendees develop a greater understanding of the Pre-Submission process by reviewing relevant sections of the updated guidance. The presenter will also discuss the Early Submission Requests eSTAR (PreSTAR) Beta Version for Pre-Submissions.

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