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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.
New York's Latest Cybersecurity Commitment
On Aug. 9, 2023, Gov. Kathy Hochul introduced New York's inaugural comprehensive cybersecurity strategy. In sum, the plan aims to update government networks, bolster county-level digital defenses, and regulate critical infrastructure.
Law Firms are Reducing Redundant Real Estate by Bringing Support Services Back to the Office
A trend analysis of the benefits and challenges of bringing back administrative, word processing and billing services to law offices.
Bit Parts
Summary Judgment Denied Defendant in Declaratory Action by Producer of To Kill a Mockingbird Broadway Play Seeking Amateur Theatrical Rights
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.