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 late June, the agency announced 26 additions and 42 modifications to the list of FDA Recognized Consensus Standards. Notable among the new standards added to the list is the 3-part ISO/ASTM 52926 series of standards that address issues related to the use of additive manufacturing in the production of metal materials. Newly added standards also include ISO 17665, which addresses the use of moist heat in the sterilization of health care products.
Read the updated Recognized Standards list as published in the Federal Register
