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October 29, 2021

Health Law Weekly

HHS Unveils New Steps to Expand Access to Rapid COVID-19 Tests

  • October 29, 2021

The Department of Health and Human Services (HHS) announced October 25 a series of new steps to expand access to reliable, over-the-counter (OTC) COVID-19 tests for at-home use at an affordable price.

As part of the administration’s ongoing effort to ramp up COVID-19 testing, the National Institutes of Health (NIH) is investing $70 million of funding from the American Rescue Plan to launch a new Independent Test Assessment Program, which will identify manufacturers with the potential to produce high-quality tests at significant scale.

The program is an extension of the NIH Rapid Acceleration of Diagnostics (RADx) initiative, which was launched at the beginning of the pandemic to jump start innovation for COVID-19 testing technologies.

Under the new program, NIH, HHS, Food and Drug Administration (FDA), and Centers for Disease Control and Prevention experts will assess and conduct studies on OTC tests and help companies to compile data and work towards the right benchmarks so they can provide the best submissions possible for the FDA’s regulatory review.

“Working hand-in-hand with FDA, NIH will produce the precise data needed to make authorization decisions quickly,” said NIH Director Francis S. Collins, M.D., Ph.D. “This close partnership will streamline the process to generate the data for FDA review.”

The FDA also separately moved to facilitate OTC single-use testing for those tests currently authorized only for serial testing. Developers of those tests may now request authorization to add single-use testing for symptomatic individuals without submitting additional data. The change will allow tests that currently are sold in two-packs to purchase them individually, potentially at a lower price, HHS said.

“These actions will help put more tests on shelves when people go to buy an at-home test, unlocking more options and potentially lowering prices,” HHS said.


  • Coronavirus Pandemic