The FDA has been under heavy pressure to ease its regulations on diagnostics to get more tests into the field for the SARS-CoV-2 coronavirus, which causes the COVID-19 respiratory disease. Clinicians and public health authorities have claimed that not enough tests are available to meet demand, so the agency has made a series of regulatory changes over the last several weeks that relax its oversight.
The March 16 policy could be the biggest revision yet. One change includes a move that lets states that wish to do so take over regulatory oversight of diagnostic tests that up to now have been regulated by the FDA. The FDA said the change extends to other states the authority the FDA gave last week to the New York State Department of Public Health to approve diagnostic tests within the state.
The second part of the new guidance lets commercial test developers sell their products on the market without the need for an emergency use authorization (EUA). Under the February 29 guidance, the FDA granted EUA waivers to labs that are certified to perform high-complexity testing, but commercial vendors were not covered by that policy.
In a third change, the FDA provided guidance to developers of serological tests, which test the blood for signs of coronavirus infection. The agency said that while serological tests are less complex than molecular tests and only identify antibodies, it does not intend to object to vendors developing these tests for SARS-CoV-2 infection.
Sweeping away barriers
The new changes demonstrate the extent to which the FDA is willing to sweep away barriers to getting more tests into the field, while still maintaining some of its oversight responsibilities.
"The policy is intended to achieve a balance between providing regulatory flexibility while allowing for critical scientific rigor," said FDA Commissioner Dr. Stephen Hahn. "We urge the state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests."
With respect to allowing states to regulate diagnostics, Hahn said that the policy would only extend to those states that wish to take on oversight themselves, like New York. State health authorities can act as "surrogates" for the FDA in these cases, Hahn said, and labs developing tests can interact directly with these regulators.
When it comes to changes to EUA rules, the FDA said that diagnostic tests developed by commercial manufacturers can be used in patients before getting emergency authorization. The FDA is requiring that it be notified within 15 business days that such use is occurring, and that labs and vendors be transparent in how they validate the tests. The FDA will then review this data.
The changes upend the traditional regulatory pathway by which the FDA reviews medical devices and diagnostics. But the agency said it has changed its approach based on the evolving nature of the coronavirus pandemic and in an effort to make more tests available.
Indeed, the agency defended its actions on a March 16 conference call with the news media. The agency noted that it had granted approvals to Roche and Thermo Fisher Scientific for high-throughput coronavirus tests within 24 hours of receiving applications. And on March 16 the agency approved two additional tests, one from LabCorp and another from Hologic.
"We have been working with industry and laboratory test developers since January," Hahn said in response to a question about whether the agency has acted quickly enough. "The situation is constantly evolving. We are committed to adapting to the evolution of this outbreak with as much flexibility as possible."
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