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What Regulatory Changes will Enable Rapid at Home COVID Testing

At home paper antigen tests could be used to screen more than 50 million Americans for COVID-19 and bring back normalcy to the country. This technology works and is available but illegal to sell. Rapid test fall under a statue known as CLIA (Clinical Laboratory Improvement Amendment). The CMS issues regulations that implement the CLIA Law, which sets standards for quality testing for “diagnosis, prevention, or treatment of disease or assessment of health”. CMS classifies these test as diagnostics and subject to FDA regulation. Paper strip tests do not meet the FDA’S high sensitivity requirements for diagnostic tests. The sensitivity criteria that the FDA is enforcing for diagnostics tests is very rigid. 

#1 Use Standard FDA Regulations

The path with minimal change would seek approval for paper antigen tests under existing guidelines for diagnostics tests under CLIA labs, using an emergency use authorization (EUA)

#2 Broaden FDA’S State-Authorization Path 

To accelerate the development of diagnostics tests, the FDA in March 2020 opened an alternative to the ordinary path involving EUA submissions, under which governors can take responsibility for authorizing and validating new test developed and performed by in their states.

#3 Relax FDA’s Template for Non-Regulatory Testing