WASHINGTON, June 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final amendment and final order classifying a device designed to detect bacterial protease activity in chronic wound fluid. This action places the device into Class II, subject to special controls, aiming to ensure its safety and effectiveness while enhancing patient access to beneficial innovations and reducing regulatory burdens.

This classification was facilita . . .

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