FDA WARNING_LETTER - Innovative Sterilization Technologies LLC - March 20, 2019

The FDA issued a Warning Letter to Innovative Sterilizations Technologies, LLC, for marketing the ONE TRAY Sealed Sterilization Container without proper marketing clearance or approval. The One Tray, classified under 21 C.F.R. 880.6850, was originally cleared for flash sterilization for immediate use (K052567).

However, the firm's website promotes the One Tray for two new intended uses: terminal sterile storage and terminal sterile storage with retained moisture. These uses represent major changes to the device's intended use, raising new safety and effectiveness questions, including increased microbial contamination risk, especially with retained moisture during storage. The FDA has not cleared or approved a rigid reusable sterilization container for terminal sterile storage with retained moisture, and the firm has not provided evidence to substantiate the safety and efficacy of these new uses.

The FDA determined the One Tray is adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) for the device as currently marketed. It is also misbranded under section 502(o) for introducing the device into interstate commerce with major changes to its intended use without submitting a new premarket notification (510(k)).

The FDA previously notified the firm of these issues during inspections in November 2015 and April 2017, and in