FDA Product Code FRC: Indicator, Biological Sterilization Process

Ensuring the effectiveness of sterilization cycles is a patient safety requirement in every healthcare setting. FDA product code FRC covers biological sterilization process indicators.

These indicators contain highly resistant bacterial spores that are killed only if the sterilization cycle achieves the required parameters. They provide the most stringent validation of steam, EO, or other sterilization processes, and their use is mandated by accreditation standards.

FRC devices are Class II medical devices, regulated under 21 CFR 880.2800 and reviewed by the FDA General Hospital panel.

Leading manufacturers include STERIS Corporation, 3M Company and Advanced Sterilization Products.