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 early August, the agency announced 29 additions and 25 modifications to the list of FDA Recognized Consensus Standards. Notable among the new standards added to the list are ISO 60601-2-35, which details requirements for the safety and performance of heating devices, and IEC 810001-5-1, which addresses the security in the product lifecycle of health software and health IT systems.
Also newly added to the list of recognized standards is ISO/TS 11137-4, which addresses process control on the use of radiation in the sterilization of healthcare products.
View the updated Recognized Standards list as published in the Federal Register.
