U.S. FEDRegulation
FDA classifies at-home STI nucleic acid detection system as class II device
The Food and Drug Administration classified the system for detecting nucleic acid from non-viral microorganisms causing sexually transmitted infections using home-collected specimens into class II with special controls. The agency determined the classification gives reasonable assurance of the device's safety and effectiveness and said it should expand patient access to innovative devices by reducing regulatory burden. The order took effect October 9, 2026.
Key points
- Device detects nucleic acid from non-viral STI pathogens in home-collected specimens.Federal Register
- Classified into class II (special controls) by final order.Federal Register
- Special controls become part of the codified classification language.Federal Register
- FDA says the move reduces regulatory burden and expands patient access.Federal Register
- Order effective October 9, 2026; the classification has applied since November 15, 2023. Published as 91 FR 64611.Federal Register
- Amends 21 CFR part 866 (FR Doc. 2026-20727).Federal Register
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Filed under
RegulationU.S.FDA Class II Classification: Nucleic Acid Detection System for STIs Using Home-Collected Specimens (2026)HealthcareFor practitionersFor governance