FDA Loosens Approval Process for Coronavirus Tests

Restrictions on coronavirus testing were somewhat relaxed by the U.S. Food and Drug Administration according to a Monday statement by FDA Commissioner Stephen Hahn.

States can now put a system in place that allows testing labs to report directly to state authorities instead of the FDA. Manufacturers of coronavirus tests can, under some circumstances, distribute and use tests of their own devising without obtaining an Emergency Use Authorization from the FDA for a period of 15 days. Serological tests, which identify antibodies present in the system when fighting off a particular infection, can also be used if the test has been validated, the FDA has been notified, and warnings that the tests have not been reviewed by the FDA are included.

"We believe the unprecedented policy set forth in today's updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories," Hahn wrote Monday.

"We know that people want to know the current numbers of tests in the field and how many patients are being tested," Hahn continued. "This number fluctuates daily as more and more test developers get their tests in the field and start testing patients. At this time, the FDA is focused on making sure tests are distributed and that test developers and labs have the materials they need to run the tests."

Laboratories in New York are already reporting to the New York State Department of Health, but the FDA's announcement expands that to all states impacted by coronavirus.

Recent data indicated that New York had 967 confirmed cases of coronavirus while Washington has reported over 904 positive cases. At 47 deaths, Washington has the highest casualty rate from coronavirus complications in the country.

Newsweek reached out to the Washington State Public Health Department for comment but did not receive a response in time for publication.

stephen hahn
FDA Commissioner Stephen Hahn announced new regulations designed to create easier access to coronavirus testing on Monday. Saul Loeb/AFP/Getty

Washington Governor Jay Inslee issued an emergency proclamation Monday to close dine-in restaurants, bars, theaters, gyms and other public gathering places. Inslee's restrictions did not apply to grocery stores, child care or daycare facilities, or restaurants who provide food for take out or delivery.

"Hours count," Inslee said during a Monday news conference. "It's not that weeks count, hours count. So we need very strong measures to reduce the extent and pace of this infestation."

New York Governor Andrew Cuomo initiated similar measures in his state as restaurants, bars and cafes closed Monday with the exception of preparing food for takeout or delivery. Movie theaters and concert venues must also close on Tuesday.

Cuomo also criticized President Donald Trump's coronavirus response during a Monday news conference citing the need for federal leadership.

"You see a whole hodgepodge of efforts being taken across the country," Cuomo said. "This state is doing this, this state is doing this, this city is doing this. It's chaos. I think it actually feeds the feeling that the country is out of control."

During Monday's coronavirus news briefing, Trump said that Governor Cuomo can "do more."

"[New York is] an area of the country that's very hot right now," Trump said, calling New York suburb New Rochelle an "area that needs to be tamped down even more because it's a hotbed, no question about it."

Speaking about the relationship between the White House and governors Trump said,
"I think it's important that all of the governors get along very well with us and that we get along with the governors, and I think that's happening."

Coronavirus COVID-19 United States Statista
Spread of COVID-19 virus across the U.S. Statista

World Health Organization advice for avoiding spread of coronavirus disease (COVID-19)

Hygiene advice

  • Clean hands frequently with soap and water, or alcohol-based hand rub.
  • Wash hands after coughing or sneezing; when caring for the sick; before; during and after food preparation; before eating; after using the toilet; when hands are visibly dirty; and after handling animals or waste.
  • Maintain at least 1 meter (3 feet) distance from anyone who is coughing or sneezing.
  • Avoid touching your hands, nose and mouth. Do not spit in public.
  • Cover your mouth and nose with a tissue or bent elbow when coughing or sneezing. Discard the tissue immediately and clean your hands.

Medical advice

  • If you feel unwell (fever, cough, difficulty breathing) seek medical care early and call local health authorities in advance.
  • Stay up to date on COVID-19 developments issued by health authorities and follow their guidance.

Mask usage

  • Healthy individuals only need to wear a mask if taking care of a sick person.
  • Wear a mask if you are coughing or sneezing.
  • Masks are effective when used in combination with frequent hand cleaning.
  • Do not touch the mask while wearing it. Clean hands if you touch the mask.
  • Learn how to properly put on, remove and dispose of masks. Clean hands after disposing of mask.
  • Do not reuse single-use masks.
FDA Loosens Approval Process for Coronavirus Tests | U.S.