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# Panel to Consider OTC Infectious Disease Tests
- URL: https://www.fdaweb.com/panel-to-consider-otc-infectious-disease-tests/
- Published: 2016-08-09T12:00:00.000Z
- Updated: 2026-09-14T21:22:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136449

The FDA Microbiology Devices Panel of the Medical Devices Advisory Committee meets August 16 to consider over-the-counter diagnostic tests for detecting pathogens causing infectious diseases. An agency [executive summary](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM515522.pdf?ref=fdaweb.com) released in advance of the meeting says the panel will discuss the risks and benefits of OTC diagnostic tests for detecting selected pathogens causing viral respiratory infections such as influenza; pharyngitis due to Group A streptococcus; and sexually transmitted infections, focusing on *Chlamydia trachomatis* and *Neisseria gonorrhoeae*.

The paper says there is precedent for FDA approval of OTC diagnostic devices for infectious diseases, citing the 2012 approval of OraSure Technologies’ OraQuick In-Home HIV Test. “Since this pioneering action,” it says, “there has been increased interest from test developers and others in expanding the availability of OTC diagnostic tests for other infectious diseases.” CDRH’s Division of Microbiology Devices says it has received multiple inquiries through FDA’s pre-submission program on the appropriate regulatory pathway for OTC diagnostic tests intended to detect infectious diseases.

Questions the panel will discuss include: 

- Do you agree with the benefits and risks described by FDA for OTC testing of influenza, Group A streptococcus, and chlamydia and neisseria?
- What measures would be appropriate to mitigate risks associated with OTC diagnostic tests for detecting each of the three pathogens?
- What would be recommended minimum performance criteria for testing each pathogen?
- What recommendations would ensure that individuals representing the appropriate intended use population are enrolled in the clinical studies to demonstrate the device performance and support OTC claims for each of the pathogens? and
- What are appropriate ways to connect patients to healthcare services should OTC tests for the pathogens being discussed become available?