FDA Issues New Policy to Help Labs to Respond to Coronavirus Threat

People wear surgical masks as they walk along Chinatown's Grant Avenue in San Francisco, California on Feb. 26, 2020. Justin Sullivan/Getty Images

The Food and Drug Administration (FDA) issued a new policy on Feb. 29 for laboratories engaged in developing diagnostic tests for the coronavirus, allowing them to immediately respond to the public health emergency.

The new policy allows certain laboratories in the United States to develop testing capabilities in a health care setting.

The FDA said in a release that the policy provides guidance for test developers and will allow certain laboratories to immediately use the test kits they had already developed.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

FDA Commissioner Stephen M. Hahn said that the policy strikes the right balance during this time of health emergency.

“We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S.,” he said.

The policy is critical because the potential threat posed by the novel coronavirus to public health is high around the world and in the United States, according to the FDA.

The coronavirus was first reported in Wuhan City, Hubei Province, China, and is currently detected around 50 countries around the world, including in the United States.

A support operations tent is seen at an earmarked quarantine site for healthy people potentially exposed to the novel coronavirus, behind Washington State Public Health Laboratories in Shoreline, north of Seattle, Washington on Feb. 28, 2020. David Ryder/Reuters

“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical,” said the FDA, adding that to a wide range of testing capabilities is required to achieve this.

Shuren said this step will help laboratories around the United States immediately respond to the urgent health care situation.

The policy is applicable to only those laboratories that have been certified to perform the high-complexity testing under the Clinical Laboratory Improvement Amendments.

“This step may reduce development costs, speed the process for availability at more testing sites, incentivize private development and, ultimately, help save lives,” said Rick Bright, director of the Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response.