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 March, the agency announced additions, withdrawals, and revisions to the list of FDA Recognized Consensus Standards. Notable among the almost 30 new standards added to the list is the Second Edition of ISO 10993-18, “Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process.”
Additions also include several ISO/ASTM standards related to the use of additive manufacturing technologies in the production of materials used in in vitro diagnostic (IVD) medical devices
