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Risk Assessment and Post-Market Programs
How do the medical device industry and the FDA prevent risks to the end user once the product is marketed? There is no simple answer to this question. Post-market vigilance in terms of risk assessment involves complex issues. These issues involve a cost/benefit analysis in terms of a “best approach” to post-market co-vigilence. The FDA has specified programs in terms of post-market risk prevention. For example, the 1976 Medical Device Amendments, the 1990 Safe Medical Device Act and 1992 Medical Device Amendments have served as milestones in medical device legislation, resulting in a system in which manufacturers must track the device from manufacture through distribution to assure accurate tracing in the event of problems. The regulations for tracking are found in 21 CFR Part 821.
The Food and Drug Administration Modernization Act of 1997 went even further in terms of legislating a medical device surveillance network for adverse events. The system, called MedSuN, is aimed at improving the protection of the health and safety of patients, users, and others involved with medical devices. The Medical Device User Fee Modernization Act of 2002 (MDUFMA) went still further on the subject of post-market surveillance in terms of Congressional appropriations and accountability.
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Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?