“We continue to see problematic claims” in connection with serology tests, Stenzel said, which are listed under policy D in the agency’s FAQ series. Under this policy, a serology test can be conducted only in a clinical lab only that is certified under CLIA to perform high-complexity tests. Stenzel said false positives are a significant risk that the FDA remains concerned about, and the agency will in the coming days and weeks seek to highlight those concerns, even in connection with highly specific tests deployed in very low-prevalence areas. He said to stay tuned on this and several other considerations.
The FDA has spent a fair amount of time on some questions surrounding the use of additive manufacturing for nasopharyngeal swabs. Stenzel said the agency has seen some creative ideas but suggested that sponsors contact the agency for advice.
State governments may authorize lab-developed tests (LDTs), although the FDA’s policy is to limit such a practice for entities certified under CLIA for high-complexity tests. New York, for example, is known for state regulation of clinical labs. However, FDA policy is not prescriptive as to how the states will determine the LDT authorization process. Stenzel said the agency prefers that any associated collection devices be vetted by the agency, however.
The FDA can withdraw the EUA for a specific test if it is not performing, but Stenzel said the agency would first contact the developer to find a useful path for sustaining test availability. This was done in connection with the ID Now test by Abbott, and Stenzel said the emphasis will be to develop an understanding of the performance issues before pulling the plug on a EUA.
Stenzel said he does not foresee the COVID-19 EUA mechanism disappearing anytime soon, adding that it may be in place for another year. This hinges on the expectation that the virus will resurface in the coming flu season and that “herd immunity” will not have been accomplished by then, particularly given the low likelihood that a vaccine will be available at any point in 2020. He advised that if a test developer files a conventional premarket regulatory filing for a EUA test, the statute allows the agency to declare that any similar devices no longer fall under the EAU mechanism. However, he said the FDA would undertake such a move “only very carefully” due to the need to ensure test availability.
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