FDA Grants Six-month Extension for Transition from Steris

The US Food and Drug Administration has allowed a six-month extension to health care facilities in order to transition from Steris Corporation’s medical device sterilization product to legally marketed alternatives.

Steris did not seek FDA clearance for a modified version of its System 1 (SS1) sterilization and disinfection device, prompting the agency to order a discontinuation of the product’s use in December 2009. Since then, the FDA has warned that it cannot verify Steris’s labeled claims regarding safety and effectiveness, and has sought to identify viable replacement products cleared for sale in the US.

Health care providers are expected to switch to other sterilization products “as soon as practicable,” but the FDA has stated that it does not anticipate taking regulatory actions against entities that do not swap out SS1 products within the extended transition timeframe. This qualifier, coupled with the regulator’s move to extend the compliance deadline, may indicate challenges finding suitable replacement devices.

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