About: Steris System 1 FDA Notice 12/03/09   Sponge Permalink

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FDA is issuing a notice to healthcare facility administrators and infection control practitioners that conveys agency concerns about the Steris System 1 Processor (SS1). FDA has not approved or cleared the currently-marketed SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices. FDA is also issuing a letter to STERIS Corporation (STERIS) notifying the firm that FDA may take regulatory action against it regarding the SS1 and its components and accessories.

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  • Steris System 1 FDA Notice 12/03/09
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  • FDA is issuing a notice to healthcare facility administrators and infection control practitioners that conveys agency concerns about the Steris System 1 Processor (SS1). FDA has not approved or cleared the currently-marketed SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices. FDA is also issuing a letter to STERIS Corporation (STERIS) notifying the firm that FDA may take regulatory action against it regarding the SS1 and its components and accessories.
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  • FDA is issuing a notice to healthcare facility administrators and infection control practitioners that conveys agency concerns about the Steris System 1 Processor (SS1). FDA has not approved or cleared the currently-marketed SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices. FDA is also issuing a letter to STERIS Corporation (STERIS) notifying the firm that FDA may take regulatory action against it regarding the SS1 and its components and accessories. On July 31, 2008, STERIS provided a written response to FDA disagreeing with the agency’s assessment that a new 510(k) was required under the agency’s regulations. Subsequently, STERIS and FDA met to discuss the warning letter. Although the parties continue to disagree about the statements in the warning letter, STERIS agreed to submit a new premarket notification for an updated STERIS System 1, which includes the changes referenced above and other technology updates. STERIS submitted this new 510(k) to FDA on January 5, 2009. FDA has stated that if you have an acceptable alternative to the SYSTEM 1 processor to meet your sterilization needs, you should transition to that alternative.
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