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

Stay informed and stay ahead in the dynamic world of FDA 510(k) premarket submissions with a comprehensive webinar. Expert guides will provide insights into the latest changes in guidance documents, recognized standards transition periods, and the implementation of the electronic Submission Template And Resource (eSTAR) system. Key areas such as software, cybersecurity, and human factors will be covered, explaining how these updates impact medical device and IVD 510(k) submissions.

Learn in this on-demand webinar about upcoming deadlines for standards transitions and eSTAR implementation, and gain clarity on compliance timelines and requirements. Discover the benefits of eSTAR for streamlining the submission process, accelerating reviews, and minimizing errors. Enhance your regulatory expertise, ensure compliance with the latest updates, and set your medical device on the path to success.

Download the presentation below, or watch the webinar on-demand.

Post date: September 19, 2023
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