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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.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
Judge Rules Shaquille O'Neal Will Face Securities Lawsuit for Promotion, Sale of NFTs
A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.
Blockchain Domains: New Developments for Brand Owners
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.
Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.