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FDA Regulation of Digital Health

Conducted by: Dr. Michael (Moshe) Kasser
SKU: 231107
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Unlike established medical device technologies, the regulatory framework for digital health products is still evolving as FDA is deciding when and how it wishes to regulate this increasingly important medical sector.  This course provides and overview of how FDA regulates digital health and goes through the most significant FDA guidance and case work to date.  Special attention is provided to...Continue reading

Unlike established medical device technologies, the regulatory framework for digital health products is still evolving as FDA is deciding when and how it wishes to regulate this increasingly important medical sector.  This course provides and overview of how FDA regulates digital health and goes through the most significant FDA guidance and case work to date.  Special attention is provided to delineate when FDA will regulate and when they will use enforcement discretion, understanding FDA’s data expectation for algorithm validation, and imaging diagnosis.

If necessary this course can be translated and given in English   

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Date:  3 July, 2024

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    Course location: Bioforum Offices, 5 llan Ramon, Ness Ziona
    Duration: 1-Day Course
    Hours: 09:00 - 17:00
    Credits: 1
    Course Language: English

    Course price: ₪2,100 + VAT
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    Have a question? We got all the answers

    Issues to be covered

    • FDA definition of digital health and recent initiatives
    • How FDA regulates medical devices
    • General wellness vs. medical device
    • Clinical decision support software
    • Interacting with FDA
    • Software validation
    • Algorithm validation
    • Regulation of image analysis software

    Who should attend

    • Regulatory personnel at digital health companies
    • Decision makers at digital health companies
    • Investors in digital health technologies.

    Benefits to the Participants

    By the end of the course the participants will understand:

    • if they are likely to be subjected to FDA regulation
    • what documentation is needed if they are not regulated
    • what are the next steps if they are actively regulated

    About The Lecturer

    Michael (Moshe) Kasser
    Michael (Moshe) Kasser is the man on ground for Hogan
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    תחזוקת מערכת האיכות בזמן מלחמה QMS

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