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HHS Launches New Program to Speed Up COVID-19 OTC Test Regulatory Process

NEW YORK – The US Department of Health and Human Services on Monday announced that it is taking several new actions to accelerate the regulatory process for over-the-counter COVID-19 tests.

The National Institutes of Health will invest $70 million from President Joe Biden's American Rescue Plan to bring more at-home tests to market in coordination with the US Food and Drug Administration, HHS said in a statement. The FDA is also streamlining the regulatory pathway for OTC at-home tests.

As an extension of NIH's Rapid Acceleration of Diagnostics initiative, the agency is establishing its new Independent Test Assessment Program, which will create an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing.

Experts from HHS will assess OTC tests and work with companies to compile necessary data, work toward performance benchmarks, and support other needs to help test developers submit their tests for FDA review. NIH will "provide reliable, independent laboratory and clinical data to the FDA for test manufacturers that can scale up quickly," HHS said.

Through the new program, HHS will prioritize new OTC test applications to accelerate the availability of rapid tests to the public, it said.

In addition, the FDA is providing recommendations for labeling updates allowing OTC single-use testing for symptomatic patients for tests that currently only have Emergency Use Authorization for serial testing. As a result, developers will be able to request authorization to add single-use testing for symptomatic people without submitting additional data to the FDA.

In line with the change, Quidel's QuickVue at-home test has been reauthorized to provide OTC single-use testing for symptomatic adults and children, HHS noted.

Additionally, the FDA last week authorized Celltrion's lateral flow immunoassay, the DiaTrust COVID-19 Ag Home Test, for OTC, single-use to test symptomatic adults and OTC serial testing for all adults for SARS-CoV-2.

"Access to easy-to-use, affordable and reliable COVID tests is key to bringing peace of mind to our families, especially as we approach winter," HHS Secretary Xavier Becerra said in a statement.