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Navigating the De Novo Pathway

Conducted by: Ms. Shoshana Friedman, Ms. Bosmat Friedman
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The purpose of this seminar is to provide participants with a comprehensive overview of the Request for Evaluation of Automatic Class III Designation under 513(f)(2) of the FD&C Act, also known as the De Novo pathway. Participants will learn about the pre-de novo submission (PDS) process, the contents of de novo application, the FDA review process and timelines, and...Continue reading

The purpose of this seminar is to provide participants with a comprehensive overview of the Request for Evaluation of Automatic Class III Designation under 513(f)(2) of the FD&C Act, also known as the De Novo pathway. Participants will learn about the pre-de novo submission (PDS) process, the contents of de novo application, the FDA review process and timelines, and key guidance documents.

We will also present case studies to help participants get a better understanding of the information they learn through real-world examples.

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Dates: 
  • 11/03/2024
  • 14/03/2024

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    Course location: Zoom Course
    Duration: 1-Day Course
    Hours: 15:00 - 18:30
    Credits: 1
    Course Language: עברית

    Course price: ₪2,300 + VAT
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    Issues to be covered

    Upon completion of this seminar, participants will:

    • Understand the FDA de novo pathway
    • Recognize the role of the PDS
    • Know what is required for a de novo application
    • Understand how FDA processes a de novo submission

    Who should attend

    Regulatory, technical, clinical and quality personnel with basic knowledge of the classification and pre-marketing processes of medical devices in the US who are interested in getting a comprehensive understanding of the FDA de novo process.

    Benefits to the Participants

     

    • History and legal background of the de novo pathway
    • Pre-de novo submission (PDS)
    • Preparation and submission of a de novo application
    • FDA review process and timelines on de novo application
    • Case studies

    About The Lecturer

    Shoshana Friedman
    Shoshana (Shosh) Friedman is Founder and Managing Director of ProMedoss,
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    Bosmat Friedman
    Bosmat Friedman is Managing Director of ProMedoss. She has been
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    תחזוקת מערכת האיכות בזמן מלחמה QMS

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