[Emergo, UL] Webinar: Determining when to utilize the Pre-Submissions Q-Submission (Pre-Sub) Process

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▶ 주제: Determining when to utilize the pre-submissions Q-submission (Pre-Sub) Process

▶ 일시: 2025년 02월 12일 CST 9시 (한국시간: 02월 13일 00시)

 

In many cases, a manufacturer must submit a marketing submission (such as a 510(k)) to the U.S. Food and Drug Administration (FDA) and have it authorized before they can start selling that device in the U.S. But what if a manufacturer has questions about what the U.S. FDA will expect to substantiate the safety and effectiveness of the device? A Pre-Submission Q-Submission (Pre-Sub) is an opportunity to interact with the FDA to obtain its feedback.

Pre-Subs may be utilized to confirm testing requirements, clinical trial design expectations, real-world evidence evaluation for the expansion of indications for use and for other purposes. We at Emergo by UL will share practical information intended to equip manufacturers with how to determine when a Pre-Sub is best utilized and how to optimize a Pre-Sub, enabling the FDA to provide actionable feedback.  

 

 

Determining when to utilize the Pre-Submissions Q-Submission (Pre-Sub) Process | Emergo by UL

Determining when to utilize the Pre-Submissions Q-Submission (Pre-Sub) Process