This article was originally published in The Gray Sheet
Executive Summary1Draft guidance released Dec. 12 updates and clarifies FDA's review process for 510(k) devices labeled as sterile, particularly those utilizing novel sterilization methods. The draft also explains what information to include in the 510(k) submissions. An increasing number of such devices rely on non-traditional sterilization methods, such as chlorine dioxide, high-intensity light or microwave radiation, which may carry substantial risk to human health, FDA says. The agency plans to inspect the manufacturing facilities before clearing a 510(k) device sterilized in a non-traditional way. The guidance does not apply to sterilizers themselves, reusable medical devices that are reprocessed in clinical settings or reprocessed single-use devices. Comments are due March 12, 2009
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