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New Regs for Reprocessed Single-Use Devices
Single-use medical devices (SUDs) are designed and approved by the FDA to be used once and thrown away. The practice of cleaning and reusing disposable medical devices has resulted from hospitals' continuing search for cost-cutting alternatives. The safety and efficacy of reprocessing SUDs has been the subject of significant – and heated – debate.
The primary debate arose in the late 1990s, when the FDA held original equipment manufacturers (OEMs) to stringent regulatory standards but exercised its “regulatory discretion” not to hold third-party reprocessors to the same standards. On Oct. 26, 2002, President Bush signed the Medical Device User Fee and Modernization Act of 2002 (the Act), Pub. L. 107-250, which reforms the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. ' 321, et seq. The Act drastically reforms the FDA's regulation of the practice of reprocessing SUDs. Recent regulations published by the FDA address many of the concerns regarding patient safety – primarily, the risks of infection and device destabilization – that were at the center of the debate surrounding reprocessed SUDs.
The Business of Reprocessing Single-Use Devices
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.
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.
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.
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?
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.