FDA WARNING_LETTER - Steris Corporation - February 09, 2011

The FDA issued a Warning Letter to STERIS Corporation regarding its Verify SixCess Class 6 Challenge Packs and Chemical Indicators. The FDA reviewed promotional materials and the company's website, finding that STERIS was making claims for these devices that were not cleared during their 510(k) submissions.

Specifically, the cleared intended uses for these chemical indicators and challenge packs involve monitoring specific steam sterilization cycle parameters. However, STERIS's promotional materials, including package inserts, brochures, and flyers, contained objectionable claims. These claims implied that the devices could be used for "immediate release of all loads," "eliminate 'blind' release," "measure Sterility Success," and were "cleared for the release of all loads & all items in the load, regardless of content," including loads with implants.

The FDA stated that these claims represent a major modification to the devices' Intended Use and Indications for Use, requiring a new 510(k) submission under 21 CFR Part 807.81(a)(3)(ii). The letter emphasized that chemical indicators do not replace biological indicators, which monitor microbicidal function, and that STERIS's representation of FDA's position on Class 6 indicators for implant loads was misleading.

These violations cause the devices to be misbranded under section 502(o) of the Federal Food, Drug and Cosmetic Act. STERIS was required to notify the FDA within 15