FDA guidance targets biological indicators
Device Regulation Alert: Safety, Compliance and Reimbursement News, October 15, 2007
The FDA released guidance for premarket submissions of biological indicators (BI) that monitor sterilizers in healthcare facilities to prevent nosocomial infections.
The guidance applies to 510(k) submissions for Class II devices that monitor the adequacy of the sterilization processes. It does not address physical or chemical sterilization process indicators identified in 21 CFR 880.2800(b), BIs used in manufacturing, and BIs used in liquid chemical sterilization.
The guidance tells manufacturers to use a table to compare their new devices to devices already being legally marketed. The table should compare the devices' use (e.g. method of sterilization), organisms, resistance characteristics, viable spore population, and shelf-life. The guidance also recommends manufacturers give detailed descriptions of the device's design and manufacturing characteristics, address performance specifications, and demonstrate that the characteristics last throughout the device's shelf-life.
Click here to read the guidance on the FDA's Web site.
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