Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 9, 2025 Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction Identify the background, purpose, [...]
Post Marketing Issues for Medical Devices: An Introduction A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 9, 2025 Post Marketing Issues for Medical Devices: An Introduction Learn how medical device manufacturers are required to evaluate and report post-market adverse events [...]
An Introduction to Coverage, Coding, and Payment of Medical Devices – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS) A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 8, 2025 An Introduction to Coverage, Coding, and Payment [...]
Medical Device Premarket Approval Applications (PMA) and the Humanitarian Device Exemption (HDE): An Introduction A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 8, 2025 Medical Device Premarket Approval Applications (PMA) and the Humanitarian Device Exemption (HDE): An Introduction Learn [...]
An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 8, 2025 An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests [...]
Medical Device Clinical Investigations: An Introduction A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 8, 2025 Medical Device Clinical Investigations: An Introduction Determine when an investigational device exemption (IDE) is needed. Learn the components of Institutional Review Boards (IRBs). [...]
Regulation of Digital Health Products: An Introduction A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 8, 2025 Regulation of Digital Health Products: An Introduction Define the different forms of medical health technology and understand how digital health products are regulated. [...]
An Introduction to the Regulation of Combination Products for Medical Devices A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 8-9, 2025 An Introduction to the Regulation of Combination Products for Medical Devices Recognize what comprises combination and non-combination products. Understand [...]
Overview of Medical Device Law and Regulation A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 8-9, 2025 Overview of Medical Device Law and Regulation Learn the statutory framework and major statutory underpinnings for medical device regulation. Discuss the federal agencies [...]
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