ARKANSAS, USA — NOWDiagnostics Inc. of Springdale has received federal approval to market its First To Know Syphilis Test, the first at-home, over-the-counter test to detect the sexually transmitted infection.
The test provides an at-home result without a prescription in about 15 minutes, which can be used to better inform a person’s next steps with a health care provider, the U.S. Food & Drug Administration said in a news release.
The FDA reviewed the product under the agency’s De Novo pre-market review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with the De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. The special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type, the FDA said.
To read more about this story, our content partner Arkansas Business has the full story here.
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