Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Classification of the simple point-of-care device to directly detect SARS–CoV–2 viral targets from clinical specimens, (Jun 12, 2026)

By WK Editorial Staff

The FDA is taking this action because it has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device.

The Food and Drug Administration (FDA) is classifying the simple point-of-care device to directly detect SARS–CoV–2 viral targets from clinical specimens in near-patient settings into class II (special controls). The special controls that apply to the device type will be part of the codified language for classification of the simple point-ofcare device to directly detect SARS– CoV–2 viral targets from clinical specimens in near-patient settings. The FDA believes the action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens (Final Rule, 91 Fed. Reg. 35387 (June 11, 2026)).

Dates.This order is effective June 11, 2026. The classification was applicable on March 8, 2023.

FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews