Interesting concern's from Michael Mina on twitter

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While this appears to be good news and a positive step forward to increasing regular testing for public health, we still don’t have a full understanding of how to interpret these guidelines.

There are a few details that we are trying to get clarification on from the FDA.
2/x

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For Ex:

1) Does this allow schools to implement a screening program without a CLIA waiver or prescription? (both barriers to testing)

2) Will FDA designate previously approved tests for screening purposes or will the test developers need to apply for a screening claim?

3/x

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Another example:

3) Will there be a designation for the types of entities allowed to perform “screening”? i.e. schools, workplaces? How does this impact performance requirements of Ag and molecular tests if these are used for screening/serial testing?

4/x

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I’ll attend tomorrows FDA Town Hall to gain clarity on what I hope is a big step in right direction.

I thank @US_FDA for listening to science & public health experts and hopefully paving way forward on important regulatory steps to accelerate progress.

5/x

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Overall I feel this is a clear signal that public health testing is being prioritized by the @JoeBiden administration for K-8 reopenings and other public health uses. Much will be clarified in the coming days and I'll try to keep people posted w my interpretations.

6/6

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A few things that I do not think this is:

This does not look like a new pathway to get rapid at home tests available nor to make it accelerate test companies getting their tests into homes. For Over The Counter use at home, I suspect tests will need to achieve same requirements

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