Publications

publication August 25, 2025

“Visual Aids in Medical Device IFUs: Why They’re a Strategic Asset, Not Just Design” by Neil O’Flaherty

In the U.S. and other regulated markets, Instructions for Use (IFUs) for medical devices must meet high standards. Such a practice is mandated not only for safety and clarity, but also for regulatory compliance and global usability. A growing number of manufacturers now recognize that visual aids aren’t just design enhancements. They are essential tools […]

publication August 1, 2025

“How to Market a Medical Device in the U.S. — What You Need to Know” by Neil O’Flaherty

The U.S. remains one of the most competitive and tightly regulated markets for medical devices. But even with a high-quality product, many companies face costly delays—not because of flaws in the technology, but due to gaps in documentation or misunderstanding of regulatory requirements.

publication July 1, 2025

“Preparing IFUs for FDA Submission: The 4 Essential Standards You Need to Know” by Neil O’Flaherty

When preparing a medical device for the U.S. market, the Instructions for Use (IFU) is not just a user manual—it’s a regulatory document subject to FDA scrutiny. A compliant IFU must clearly communicate safe and proper product use while meeting both FDA requirements and international standards. To support this critical task, Hansem Global and Amin Wasserman Gurnani (AWG) offer a […]

publication March 12, 2025

“Novel Ingredients Take Focus in Supplement Sector” by Rend Al-Mondhiry and Robert Durkin

Regulatory Group Co-Chairs Rend Al-Mondhiry and Bob Durkin explore the regulatory hurdles surrounding the marketing of novel ingredients in dietary supplements in an article published by SupplySide Supplement Journal.

publication October 16, 2024

“AWG Legal Takeaways” – New Column by Rend Al-Mondhiry: State Restrictions on Hemp Heat Up

In our latest “AWG Legal Takeaways” column, published by SupplySide Supplement Journal, Rend Al-Mondhiry examines growing attacks against hemp products by the states and the counteroffensives by industry in the courts.

publication July 10, 2024

“Cool to be KIND: Second Circuit Rejects ‘Expert’ Survey Evidence, Ends Long-Running ‘All Natural’ Class Action” by Jennifer Adams

In a Legal Backgrounder published by Washington Legal Foundation on July 8, 2024, Jennifer Adams writes: “False advertising challenges to “all natural” and similar “natural” claims have been among the most prolific litigation trends for consumer product companies. Currently, there is no legal or regulatory definition of “natural,” and cases have either settled before reaching […]

publication June 12, 2024

“Aggressively Defending the Baseless Class Action” by William Cole and Matthew Orr

Litigators William Cole and Matthew Orr discuss the business of plum financial paydays for plaintiffs’ lawyers and strategies for defending against frivolous, baseless, pursued-in-bad-faith claims in the current issue of Nutrition Industry Executive/VRM Media.

publication May 6, 2024

“Before, During, and After FDA Inspections,” by Evan Phelps

In his article, “Before, During, and After FDA Inspections,” published by the American Health Law Association, Evan Phelps highlights practical tips and best practices for regulated facilities to prepare for inspections.

What's Now

California Restricts Sales of Weight-Loss and Muscle-Building Products to Minors

A new California law (AB 2030) prohibits the sale of over-the-counter diet pills and dietary supplements marketed for weight loss or muscle building to consumers under 18. Each violation is punishable by a civil penalty MORE >

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