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# Device Panel Supports OTC Tests for STDs
- URL: https://www.fdaweb.com/device-panel-supports-otc-tests-for-stds/
- Published: 2016-08-19T12:00:00.000Z
- Updated: 2026-09-14T21:25:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136564

FDA’s Microbiology Devices Panel has unanimously agreed that the benefits outweigh the risks for allowing over-the-counter (OTC) diagnostic tests for detecting *Chlamydia trachomatis/Neisseria gonorrhoeae*. The panel also agreed that benefits outweighed risks for OTC group A streptococcus tests. However, the panel did not come to an agreement on whether the benefits outweigh the risks for influenza OTC assays. For these tests, panel members were worried that the potential low positive predictive value outside of an active influenza season was a high risk and that risk was difficult to mitigate under the current FDA regulatory framework.