Steris Warned for Making Claims Previously Rejected by FDA

The FDA has warned Steris for marketing claims the agency deemed unacceptable during review of 510(k) submissions for the company’s chemical indicators. The labeling Steris originally submitted for its Verify chemical indicators and challenge packs claimed the indicators’ performance exceeds that of biological indicator kill, according to the Feb. 9 warning letter posted online last week. Records show the FDA advised Steris that chemical indicators should not replace biological indicators. It asked the company to revise the indication for use, product labels and 510(k) summary, and Steris provided revised documents removing the comparisons to biological indicators, the letter says.
Devices & Diagnostics Letter