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 3M Company, STERIS Corporation and Steris.
FDA 510(k) Cleared Indicator, Biological Sterilization Process Devices (Product Code FRC)
About Product Code FRC - Regulatory Context
510(k) Submission Activity
206 total 510(k) submissions under product code FRC since 1977, with 206 receiving FDA clearance (average review time: 169 days).
Submission volume has increased in recent years - 14 submissions in the last 24 months compared to 9 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FRC have taken an average of 97 days to reach a decision - down from 174 days historically, suggesting improved FDA processing for this classification.
FRC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →