Data / Federal rules / 2026-20727

Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens

The Food and Drug Administration published this final rule in the Federal Register on October 9, 2026. It took effect on October 9, 2026.

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What the agency says

The Food and Drug Administration (FDA) is classifying the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Key facts

Document number: 2026-20727
Type: Final rule
Action: Final amendment; final order
Agency: Health and Human Services Department; Food and Drug Administration
Published: October 9, 2026
Takes effect: October 9, 2026
Dates: This order is effective October 9, 2026. The classification was applicable on November 15, 2023.
Docket: Docket No. FDA-2026-N-10996
Code of Federal Regulations: 21 CFR 866
Topics: Biologics; Laboratories; Medical devices
Pages: 5

The document on federalregister.gov PDF

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Everything from the Food and Drug Administration · Rules on biologics · Rules on laboratories · Rules on medical devices · Published in October 2026

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.