Federal Register #2026-20727

FDA device classifications for home-collected STI tests and an infant vital-sign monitor

The U.S. Food and Drug Administration issued device classifications and special controls for two types of medical devices; the notice does not request a purchase or identify a vendor. - Government buyer and issuing office: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); no sub-agency office is identified. - OEMs and vendors: None named. - Device types described: - Home-collected specimen system for detecting nucleic acids from non-viral microorganisms that cause sexually transmitted infections. It is intended for specimens collected at home or similar settings and tested in a clinical laboratory; use may be prescription or over the counter. Classified as Class II with special controls and subject to 510(k) premarket notification. - Over-the-counter infant pulse-rate and oxygen-saturation monitor. The material identifies it as Class II with special controls but does not provide the full requirements. - Notable controls for the STI testing system address specimen collection, clinical and analytical validation, usability and risk analysis, labeling, shipping and specimen integrity, and public-facing user information. - No quantities, part numbers, contract value, or period of performance are provided.

Description

The FDA is classifying systems for detecting nucleic acid from non-viral microorganisms that cause sexually transmitted infections using home-collected specimens as class II medical devices subject to special controls. The order identifies the applicable special controls, which will be incorporated into the codified classification requirements. FDA states that class II classification provides reasonable assurance of safety and effectiveness and may enhance access to innovative devices by reducing regulatory burdens. The order is effective October 9, 2026; the classification was applicable on November 15, 2023.

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