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Introduction to Medical Device Law and Regulation

    https://www.fdli.org/2021/11/introduction-to-medical-device-fall-2021/
    FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind, we are excited to announce that the 2021 Introduction to Medical Device Law …

Introduction to Medical Device Law and Regulation - Food and …

    https://www.fdli.org/2022/11/introduction-to-medical-device-law-and-regulation-fall-2022/
    Explore the essentials of device law and regulation and gain a comprehensive understanding of the administrative agencies that impact this …

Introduction to Medical Device Law and Regulation - Food and …

    https://www.fdli.org/2022/04/introduction-to-medical-device-law-spring-2022/
    FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in …

Introduction to Medical Device Law and Regulation

    https://www.fdli.org/2020/04/apr-introduction-to-medical-device-law-and-regulation/
    FDA’s regulatory process for medical devices. How to prepare a successful 510 (k) submission. Registration and listing requirements. Elements of conducting …

Introductory Courses - Food and Drug Law …

    https://www.fdli.org/programs/introductory-courses/
    Introductory Courses. FDLI offers intensive training courses covering the basics of FDA law and regulation. Learn …

Overview of Medical Device Law and Regulation

    https://www.fdli.org/2022/11/overview-of-medical-device-law-and-regulation/
    Learn the statutory framework and major statutory underpinnings for medical device regulation. Discuss the federal agencies that play a role in regulating medical …

FDLI: Introduction to US Medical Device Law and Regulation

    https://www.ebglaw.com/insights/fdli-introduction-to-us-medical-device-law-and-regulation-overview-of-medical-device-law-and-regulation-organizational-structures/
    James A. Boiani and Gail H. Javitt, Members of the Firm, will co-present “Overview of Medical Device Law and Regulation Organizational Structures,” at the …

Medical Device Clinical Investigations: An Introduction

    https://www.fdli.org/2022/11/medical-device-clinical-investigations/
    Medical Device Clinical Investigations: An Introduction. Determine when an investigational device exemption (IDE) is needed. Learn the components of Institutional Review …

An Introduction to the Medical Device Approval Process: …

    https://portal.fdli.org/CPBase__item?id=a133j00000Jz8UlAAJ
    An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests Quantity Add to Cart Back to Results Recorded November 16, …

FDLI: Introduction to Medical Device Law and Regulation: A …

    https://www.ebglaw.com/insights/fdli-introduction-to-medical-device-law-and-regulation-a-program-on-understanding-how-the-government-regulates-the-medical-device-industry/
    You’ll receive an overview of the FDA regulatory structure, obtain pointers on how to prepare a successful 510(k) submission, and learn about new and developing …



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