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Innovative Sterilization Technologies (IST)/ONE TRAY in Dayton, Ohio has announced that a Warning Letter issued by FDA in March 2019 has been closed. FDA, as part of the warning letter review and correspondence, confirmed that ONE TRAY’s clearance contained a validated 48-hour storage period and has agreed that the company may use the specific language in the company’s labeling consistent with the indications for use cleared in 2006.
IST also attempted to remove the antiquated term “FLASH” without success; however, IST has agreed with FDA regarding the uses for which the device may be labeled/marketed and commercialized. During the warning letter closure process, FDA stated that “a key distinction of Immediate Use Steam Sterilization is that it cannot and should not be stored.”
The warning letter closure follows discussions surrounding sterilization terminology and acknowledges the storage of the ONE TRAY rigid sterilization container. FDA conclusions in the warning letter, which the company believes to include factual inaccuracies, does not take into consideration the following: current industry sterilization terminology, the scope of the ONE TRAY 510(k )clearance, FDA’s long-standing policy and guidance with respect to when to obtain clearance for device modifications, nor the years of interactions between the two parties (2014-current).
IST has been factual and transparent in all FDA interactions since the commercialization of ONE TRAY. In addition, management of IST has maintained that the company’s marketing has been within the scope of the industry definitions and followed FDA’s guidance of the product in accordance with published FDA guidance documents. We are accordingly pleased to have resolved this long-standing compliance concern with FDA.
Since the commercialization of ONE TRAY in 2013, there have been more than five million uses with no reported medical device reporting events. IST’s products and processes have been repeatedly reviewed by FDA, and all inspection observations have been addressed. Closure of the Warning Letter by the FDA shows compliance of IST and acknowledgment of the previously stated cleared validated 48-hour storage period.
