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regulatory guidance

The new pathway allows developers of authorized tests that meet certain requirement to immediately obtain a screening claim.

The agency cautioned test companies that the presence of mutations in the virus could lead to false negative results.

The agency identified three tests potentially impacted by known mutations, and said it will continue to monitor authorized assays.

Some tests that detect multiple SARS-CoV-2 genes are serendipitously signaling new viral variants while still effectively detecting infections.

The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.

The agency provided the update on Wednesday in its weekly virtual town hall and on its FAQ page.

While the guidance was welcome after years of uncertainty, regulatory experts say it does not provide enough detail for IVD manufacturers. 

The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.

Federal mandates requiring frequent SARS-CoV-2 testing for nursing home employees and significant purchases of rapid antigen tests from HHS have raised concerns about capacity.

IVDs in the future will require certification in England, Scotland, and Wales, while companies will still be able to sell tests in Northern Ireland under existing EU regulations.

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