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    Regulatory Essentials

    Regulatory Essentials in Health Tech: FDA

    This on-demand session gives a basic understanding of the U.S. regulations for medical and in vitro diagnostic devices. The regulatory path to the U.S. market and essential items related to the FDA and the U.S. Food and Drug Administration are reviewed.

    The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

    Topics

    • Why the USA?
    • What is a medical device and the differences in definitions
    • Intended use
    • Significant regulatory differences between EU and quality systems
    • UDI – Unique Device Identification
    • Software products, including AI
    • Costs
    • Where to get information
    • Practical lessons & stumbling blocks.

    Target group

    All health tech developers and other stakeholders interested in how to enter the US market and which are the main issues to be considered when submitting a sales approval application to the FDA.

    Objectives

    • Know the typical routes to the U.S. market and what is required in terms of contents and quality of the submission package.
    • Understand the fundamental differences between the European and U.S. regulations for medical device manufacturers.
    • Have a basic understanding of approaches by the FDA reviewers and “the U.S. way of thinking.”

    Additional information

    Following the Regulatory Essentials sessions 1-5 before this on-demand session is recommended.