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 [...]

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 [...]