Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test to Detect SARS-CoV-2 From Clinical Specimens | Federal Regulations · Congress.wiki

Rulemaking

FDA

RIN Not Assigned

FDA-2026-N-6733

Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test to Detect SARS-CoV-2 From Clinical Specimens

Documents

Comments

Description

This order is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens into class II (special controls).

Key Dates

Comment Period OpensJul 24, 2026

Documents

Type	Title	Posted	Comments	Status
Final Rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens FR Doc: 2026-14985	Jul 24, 2026

Keywords

2026-144

CDRH

Medical Devices

Immunology and Microbiology Devices

Classification of the Over-the-Counter Test to

Detect SARS-CoV-2 From Clinical Specimens

OPEN

Data from Regulations.gov