FDA Authorities and Processes for the Enforcement, Compliance, and Inspection of Medical Devices A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 9, 2025 FDA Authorities and Processes for the Enforcement, Compliance, and Inspection of Medical Devices Learn the types of [...]
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 [...]
