The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.
In a Notice published in the Federal Register in mid-February, the agency announced 31 additions and more than 75 modifications to the list of FDA Recognized Consensus Standards. Notable among the new standards added to the list are several standards related to software used in health informatics applications that address cybersecurity considerations. Newly added standards also include ASTM F624-25, which addresses the evaluation of thermoplastic polyurethane solids and solutions used in medical devices.
The text of the updated Recognized Standards list as published in the Federal Register is available at https://www.federalregister.gov/documents/2026/02/19/2026-03310/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized.