State health departments have the power to put Covid-19 tests on the market without waiting for FDA approval under a shift in policy announced by the federal agency.
The policy change gives states enormous responsibility for regulating new diagnostics that come online, a landmark move for the Food and Drug Administration to relinquish oversight over testing to meet testing demands.
Agency leaders acknowledged the policy released Monday means the FDA is taking a risk by relying on state public health departments. But they said the move was necessary to balance the needs of a pandemic with the risks the tests may be faulty.
“The state department of health can act as a surrogate for FDA,” FDA Commissioner Stephen Hahn said during a press conference. “The policy is intended to achieve a balance between providing regulatory flexibility while allowing critical scientific rigor.”
The FDA said a week ago that it wouldn’t object to the New York state health department authorizing certain laboratories there. The policy change essentially takes that decision and opens it up to all states.
States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA. Under the guidance, the system does not need to mirror that of New York. Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA. Nor will these laboratories pursue an Emergency Use Authorization with the FDA.
If the FDA finds faults with the test, they might take it off the market, but they also might work with the test developer to resolve issues.
The FDA also gave commercial manufacturers such as Roche and Thermo Fisher Scientific the same flexibility the agency extended last month to specialized laboratories at academic centers.
That policy, released Feb. 29, allowed specialized labs to develop and use their own coronavirus screening tests without waiting for FDA authorization. Those tests must still go to the FDA for approval, but the agency is providing a 15-day grace period in which the labs can use the tests to screen patients while they get their submissions together.
The guidance document also includes recommendations for test developers that want to make serological tests, which measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection.
“We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis; however, as stated in the updated guidance, the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests,” Hahn said in a statement.