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FDLI - Introduction to Medical Device Law and Regulation

Event | 03.08.10 - 03.09.10, 12:00 AM UTC - 12:00 AM UTC

In this interactive two-day program, you will learn the essential elements of medical device regulations in a systematic and comprehensive way. The first day will focus on the legal framework, FDA’s organization and pre-market requirements and the second day will focus on postmarket requirements, the Quality System Regulation (QSR), adverse events, and promotion and advertising. The program will walk you through key regulations and policies, while it helps you develop a clearer understanding of how they work. 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 FDA policies and procedures affecting all phases of medical device regulation. This program will help you to think like a seasoned medical device professional. Additionally, you will learn how FDA enforces the laws passed by Congress and some of the “hot” issues of the day. This meeting can help you and your organization stay in compliance with FDA regulations, get products approved, and help minimize regulatory problems.

Steve Niedelman will address "Quality Systems Regulation and Part 11".

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Event | 02.20.25

Has the Buss Stopped? Recoupment Today

Has the Buss Stopped? Recoupment Today: In 1997, the California Supreme Court decided Buss v. Superior Court. In Buss, the court concluded that a liability insurer that defended a mixed action could seek reimbursement from the insured for the defense costs associated with the claims that were not even potentially covered. Since then, numerous courts have held that insurers are entitled to recoup their defense costs associated with uncovered claims or causes of action. On the other hand, a significant number of courts have rejected insurers’ right to recoupment, at least in the absence of a policy provision granting the insurer that right. Some commentators have even suggested that the current judicial trend might be away from permitting insurers to recoup their defense costs. Is that correct? Has the Buss stopped? This panel of coverage experts will analyze insurers’ claimed right to recoupment today, and offer their perspectives on what the law on recoupment should perhaps be and might be in the future.

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