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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
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.