Innovative Sterilization Technologies received an FDA warning letter accusing the company of marketing its One Tray reusable sealed sterilization container for terminal sterile storage and terminal sterile storage with retained moisture, which are not covered by the device's original clearance. In the letter, the agency noted that the company did not provide evidence to support the safety and efficacy of the uses in question.
Innovative warned over marketing One Tray outside original clearance
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