Articles and Blogs

On March 31, 2025, the U.S. District Court for the Eastern District of Texas (District Court) struck down the U.S. Food and Drug Administration’s (“FDA” or “Agency”) Final Rule that would have asserted FDA’s authority to regulate laboratory-developed tests (“LDTs”) as medical devices under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) (“LDT... READ MORE

On December 27, 2024, the U.S. Food and Drug Administration (“FDA” or “Agency”) published a final rule updating the criteria for the implied nutrient content claim “healthy” that appears on food packaging. The “healthy” label serves as a quick, consumer-friendly signal on food packaging to help consumers identify foundational foods that support a balanced,... READ MORE

On December 27, 2016, the Food and Drug Administration (“FDA”) issued final guidance (the “Post-Market Guidance”) outlining steps that medical device manufacturers and health care systems should take to monitor, identify, understand and address cybersecurity risks once medical devices and mobile medical devices have entered the marketplace. The Post-Market Guidance follows October 2014 FDA... READ MORE