FDA Classifies Device for Detecting Nucleic Acids From Non-Viral Microorganisms Causing Sexually Transmitted Infections
May 09, 2025
May 09, 2025
WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified a device designed to detect nucleic acids from non-viral microorganisms causing sexually transmitted infections (STIs) and associated resistance markers into class II, subject to special controls.
The FDA's final amendment, published on May 9, 2025, is intended to provide a reasonable assurance of safety and effectiveness for these devices. The action is ex . . .
The FDA's final amendment, published on May 9, 2025, is intended to provide a reasonable assurance of safety and effectiveness for these devices. The action is ex . . .