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# FDA Cracks Down on Zika-related LDT
- URL: https://www.fdaweb.com/fda-cracks-down-on-zika-related-ldt/
- Published: 2016-03-10T12:00:00.000Z
- Updated: 2026-09-15T02:42:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135050

> FDA says a MD Biosciences laboratory-developed test for detecting Zika virus requires 510(k) clearance or PMA approval. In a [just-posted letter](http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM490077.pdf?ref=fdaweb.com) to the company, the agency says the Zika Virus RNA by RTPCR Assay, which is intended “to provide a reliable, accurate and rapid method of testing for Zika virus,” appears to meet the definition of a device. “Based on our review of your Web site and other materials, we believe you are offering a high risk test that has not been the subject of premarket clearance, approval, or Emergency Use Authorization,” the letter says. It asks the company to submit the assay’s design, validation, and performance characteristics so reviewers can assess it further.