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

In May 2024, the U.S. Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). According to the FDA, the Final Guidance is designed to help medical device servicers understand when certain device... READ MORE

On October 15, 2018, the National Protection and Programs Directorate (“NPPD”) of the U.S. Department of Homeland Security (“DHS”) and the U.S. Food and Drug Administration (“FDA”) entered into a Memorandum of Agreement (“MOA”) that formalizes a long-standing relationship between the agencies and implements a new framework for increased collaboration, information-sharing and coordination that... READ MORE

On September 6, 2017, the U.S. Food and Drug Administration (“FDA”) published final guidance (“Guidance”) summarizing its recommendations for medical devices that are connected to each other and to other technology (“interoperable medical devices”). The Guidance finalizes preliminary guidance from January 2016 and is intended to encourage rapid innovation in the marketplace by allowing... 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