That & #039;s a First: FDA Tackles STDs, Zika, and Prosthetic Joint Infection

The U.S. diagnostic market celebrated three regulatory firsts last week.  1. FDA Authorizes Marketing of First Zika Test Until now, tests for detecting Zika virus immunoglobulin (IgM) antibodies in blood were only authorized for emergency use under FDA's Emergency Use Authorization (EUA) authority. On Thursday, the agency said it has authorized marketing of the ZIKV Detect 2.0 IgM Capture ELISA under the agency's traditional premarket authority. The test is manufactured by InBios International. “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using our emergency use authorities,” said FDA Acting Commissioner Ned Sharpless, MD. Authorizing tests under EUA allowed manufacturers and the agency to respond quickly to the Zika emergency while continuing to review the safety and effectiveness of the test under the traditional regulatory pathway.  The Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. While many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to public health. Links between Zika virus infection and neurological complications (i.e., Guillain-Barré Syndrome), as well as microcephaly (abnormal smallness of the hea...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance IVD Source Type: news