THREAD: Statement on new FDA guidelines for Screening programs
Today FDA announced new guidelines for screening programs (i.e. testing asymptomatic individuals frequently to detect positive cases before they spread to others).
fda.gov/news-events/pr…
1/x
Today FDA announced new guidelines for screening programs (i.e. testing asymptomatic individuals frequently to detect positive cases before they spread to others).
fda.gov/news-events/pr…
1/x
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
There are a few details that we are trying to get clarification on from the FDA.
2/x
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
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
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
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
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
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
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
6/6
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
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
• • •
Missing some Tweet in this thread? You can try to
force a refresh
