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regulatory guidance

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.

The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.

The agency has provided new guidance for tests that can be used outside of a lab setting, as well as updated its guidance on a number of other topics.

The guidance suggests validating a five-sample pooling strategy, but notes that this may need to be adjusted depending on assay sensitivity and local prevalence.

Recent guidance from HHS has improved data collection by clarifying which testing data all laboratories must report, including demographic data.

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