Free Webinar | Navigating Recent 510(k) Updates: Guidance Documents, Recognized Standards, and eSTAR

September 19, 2023

Date: 19 September 2023

Time: 18:00-19:00 CEST | 12:00 – 1:00 PM EST | 9:00 – 10:00 AM PDT

Location: Virtual

Language: English

Moderator: Lorry Weaver


Stay ahead in the dynamic world of FDA 510(k) premarket submissions with our comprehensive webinar. Our experts will guide you through the latest changes in guidance documents, recognized standards transition periods, and the implementation of the electronic Submission Template And Resource (eSTAR) system. Gain valuable insights to stay up-to-date with the latest changes, covering key areas like software, cybersecurity, and human factors, and understand how these updates impact your medical device and IVD 510(k) submissions. This knowledge will enable you to align your applications with the most current 510(k) requirements, significantly improving your chances of successful approval.

Learn about the approaching deadlines for FDA recognized standards transition periods and the mandatory eSTAR implementation deadline for 510(k) submissions on October 1. Drawing from our practical experiences, we'll provide clear guidance on compliance timelines and requirements, ensuring a seamless transition for your medical device submissions.

Discover the benefits of the electronic Submission Template And Resource (eSTAR) system, streamlining your 510(k) submission process, accelerating reviews, and minimizing errors. Our experts will share how this innovative system can optimize your submission workflow for improved efficiency and successful outcomes.

Don't miss this essential opportunity to enhance your regulatory expertise and ensure compliance with the latest updates. Reserve your spot now to navigate recent FDA 510(k) changes with confidence and set your medical device on the path to success.

Learning Objectives

  1. Updates to Premarket Submission Guidance Documents. Stay informed about the latest changes in FDA premarket submission guidance documents including software, cybersecurity, and human factors. Our experts will provide valuable insights into how FDA is incorporating recent updates into 510(k) reviews and explain how they can impact your medical device and IVD submissions. With this knowledge, you can ensure your applications align with the most current requirements, improving your chances of approval.
  2. FDA Recognized Standards Transition Periods for Updates. Understand the transition periods for FDA recognized standards and how they affect medical device and IVD submissions. Drawing from our practical experiences, we'll provide clarity on compliance timelines and requirements. 
  3. eSTAR Integration. Discover the benefits of the electronic Submission Template And Resource (eSTAR) system, supported by our practical experiences. Learn how eSTAR streamlines your submission process, accelerates reviews, and minimizes errors. Our experts will share insights from real cases to help you effectively integrate eSTAR into your workflow, unlocking its full potential for improved outcomes in your FDA 510(k) submissions.

Who should attend?

US manufacturers who are familiar with FDA regulations but not completely up-to-date.

Qserve host:

Michelle Hasse, MSc
Lorry Weaver, MT(ASCP), CLS(NCA)
Veröffentlicht am:: August 15, 2023
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