Regulatory Focus™ > News Articles > 2020 > 10 > FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs

FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs

Posted 08 October 2020 | By Mary Ellen Schneider 

FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs

The US Food and Drug Administration (FDA) has updated its Frequently Asked Questions on the development and performance of diagnostics for SARS-CoV-2, which includes the agency’s plan to decline to review emergency use authorization (EUA) requests for laboratory developed tests (LDTs).
That decision follows an announcement from the US Department of Health and Human Services that LDTs would not be required to undergo premarket review.
FDA will continue to prioritize review of EUA requests for point-of-care tests, home collection tests, at-home tests and any tests that reduce the reliance on testing supplies, as well as high-throughput, widely distributed tests. The aim of this shift is to increase testing accessibility and capacity, the agency said in the updated FAQs.
“We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs,” FDA wrote. “We prioritize review of EUA requests for tests taking into account a variety of factors, including those discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product.”
Swab Updates
FDA also updated its guidance on which specimen types are appropriate for swab-based testing. Nasopharyngeal, oropharyngeal, mid-turbinate and anterior nares specimens can all be collected using swabs. The agency offered additional information on the proper way to collect an anterior nares specimen, noting that poor collection technique could produce an inadequate sample for testing and decrease the sensitivity of the test.
FDA officials sent a letter to health care providers on providing instructions to patients who self-collect anterior nares samples in a health care setting.
Additionally, FDA updated information on the regulatory requirements for 3D-printed swabs, which are generally considered Class I medical devices and fall under the product code KXG. Sterile swabs that are exempt from premarket notification requirements do not require an EUA for distribution, according to FDA. Any facility that manufactures sterile swabs must register and list its product and meet applicable medical device regulatory requirements, including those related to quality system regulation, medical device reporting and reports of corrections and removals.
The agency urged manufacturers to consult its guidance on technical considerations related to 3D-printed devices.
“As a general matter, 3D printing can introduce certain challenges not seen with conventional manufacturing. FDA is aware that some users have reported concerns of brittle 3D printed swabs that have broken into multiple sharp pieces, and non-traditional capture geometries that may not capture the sample sufficiently,” FDA wrote in the updated FAQs. “While FDA and the clinical community have vast experience with traditional swabs, there is limited prior experience with the use of 3D printed swabs for specimen collection for diagnostic testing.”
Other Updates
FDA also provided an updated list of CLIA-certified laboratories offering diagnostic tests under the policy outlined in the Policy for Coronavirus Disease – 2019 Tests. The agency noted that CLIA-certified labs that meet requirements to perform high-complexity testing can use validated tests for 15 business days while preparing their EUA submission. Similarly, the agency provided an updated list of commercial manufacturers who are distributing validated diagnostic test kits under that same guidance. They are also allowed to distribute test kits for 15 business days while preparing an EUA submission.
FDA updated the list of manufacturers who have notified the agency that they have validated serology tests to identify antibodies to SARS-CoV-2 and intend to distribute them. These manufacturers have 10 business days to prepare an EUA submission. The agency also updated the list of manufacturers of serology tests that should no longer be offering tests either because they did not submit their EUA request in a reasonable period of time, there were significant problems with the test, or the manufacturers voluntarily withdrew their test notification to the FDA.


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Tags: coronavirus, FDA, US

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