Publications

publication November 5, 2025

“Trends and Developments in Dietary Supplement Class Action Lawsuits in the US” by Rend Al-Mondhiry and Jennifer Adams

The US dietary supplement industry faces an increasing risk of class action lawsuits driven by claims related to labeling, testing, and compliance. In an article just published by RAPS.org, Rend Al-Mondhiry and Jennifer Adams examine current trends in class action cases, including challenges to FDA disclaimers for structure/function claims, inaccurate protein %DV declarations, and discrepancies […]

publication November 5, 2025

“Medical Device Warning Letters Under the First Nine Months of the Trump Administration” by Evan Phelps

Savvy medical device manufacturers understand that reviewing FDA Warning Letters offers strategic, operational, and compliance benefits. For example, such information can reveal patterns regarding FDA’s evolving priorities and enforcement focus areas, which, in turn, can enable device firms to create focused, data-driven risk mitigation plans. Publicly available records indicate that at least 34 medical device-related […]

publication October 21, 2025

“How to Navigate GLP-1 Supplement Claims and Compliance” by Rend Al-Mondhiry

Interest in GLP-1 products has grown exponentially over the past year. With this growth has come questions and scrutiny around the types of claims that can be made for dietary supplements intended for GLP-1 support — and rightly so, as there are boundaries regarding what can be said about the benefits of these products, and […]

publication October 6, 2025

“Preparing for the Transition to the Quality Management System Regulation: Are You Ready?” by Neil O’Flaherty

U.S. Good Manufacturing Practices (GMPs) for medical devices are poised to change. It’s been a minute: The last time they changed was in 1996 — almost three decades ago. How Are Device GMPs Changing — and When?

publication September 23, 2025

“What Information Does the FDA Expect in Your IFU?” by Neil O’Flaherty

When entering the U.S. market, a medical device’s Instructions for Use (IFU) are not just a technical document—they are a legal requirement. As a core part of labeling regulated by the FDA, the IFU must demonstrate your product’s intended use, safety, and compliance. A well-prepared IFU can support a successful FDA product marketing submission, while […]

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 […]

What's Now

“How to Navigate GLP-1 Supplement Claims and Compliance” by Rend Al-Mondhiry

Interest in GLP-1 products has grown exponentially over the past year. With this growth has come questions and scrutiny around the types of claims that can be made for dietary supplements intended for GLP-1 support MORE >

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