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 December, the agency announced additions, withdrawals, and revisions to the list of FDA Recognized Consensus Standards. Notable among the nearly 30 new standards added to the list is the First Edition of ISO 10993-23, “Biological evaluation of medical devices—Part 23: Tests for irritation.”
Additions also include several parts of ISO 23500, “Preparation and quality management of fluids for haemodialysis and related therapies,” ISO 80601-2-58 related to the basic safety and essential performance of specific types of ophthalmic devices, and two IEEE standards related to device software and informatics.
