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 record

Publisher

Federal Register

Agency

Health and Human Services Department; Food and Drug Administration

Source

Federal Register

Kind

Federal Register: final rule

Jurisdiction

United States

Topics

Health

Importance

Notable, the middle of three tiers Kresmion sets by fixed rules from the source's own fields

Published (source time)

2026-10-09 (the source gives a date only)

First seen on Kresmion

2026-10-26 18:25 UTC

The original

• PDF (Federal Register)

Source: Federal Register (federalregister.gov). U.S. government work, public domain.

The publisher's summary

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.

The publisher's words, as published.

Federal Register document

Document number

2026-20727

Document type

Rule

Status

Published