FDA Warns IST Over Unapproved Use of One Tray®
The FDA issued a warning letter to Innovative Sterilizations Technologies, LLC (IST), for marketing the One Tray® Sealed Sterilization Container for different intended uses outside of its original clearance. FDA claims that One Tray was approved to hold reusable medical devices while they are flash sterilized for immediate use, but the product is being marketed for terminal sterile storage and terminal sterile storage with retained moisture. IST issued a statement on August 22 disputing FDA’s assertions, and claiming that One Tray’s currently marketed indication for use are within the scope of FDA’s original clearance. Read the FDA warning letter and IST’s response statement.