International Issues for Medical Device Manufacturers: An Introduction A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 9, 2025 International Issues for Medical Device Manufacturers: An Introduction Understand the legal framework concerning imports and exports of medical devices. Recall the basis [...]
An Introduction to the Regulation of Promotion and Advertising for Medical Devices A session from FDLI’s Introduction to Medical Device Law and Regulation Recorded April 9, 2025 An Introduction to the Regulation of Promotion and Advertising for Medical Devices Review the scope of FDA authority [...]
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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). [...]
