FDA Strikes Hard at Coronavirus Outbreak with New Policy

FDA is upping its response to address the novel coronavirus outbreak. The policy is aimed at laboratories seeking to develop diagnostic tests for the coronavirus. The policy allows laboratories to develop and begin to use the diagnostics before FDA has completed a review of their Emergency Use Authorization (EUA) requests. "We believe this policy strikes the right balance during this public health emergency," said FDA Commissioner Stephen M. Hahn, M.D. "We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation." Co-Diagnostics is an in vitro diagnostics firm that has been out in the forefront during the outbreak. Last month the Salt Lake City, UT-based company received CE mark Logix Smart Coronavirus COVID-19 Test. In response to FDA’s new policy, the company said it is in discussions with certain qualified CLIA laboratories who can use COVID-19 tests built on Co-Diagnostics' platform technology in their EUA submissions with FDA. Co-Diagnostics said once the labs have completed the process required for the EUA submission, it is expected that they would purchase the companyâ&...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Regulatory and Compliance Source Type: news