That original policy required vendors only to notify the agency that
they intended to sell the tests in the country and to self-certify
the tests worked. Reuters reported that the policy had opened the
market to fraud and lawmakers had pushed the FDA to change it.
The antibody tests are used to determine if a person has been
previously exposed to the new coronavirus and developed antibodies
that could prevent reinfection. Federal, state and local governments
are deploying these tests to gauge the level of immunity in
populations.
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Under the abridged rules announced May 4, vendors must apply for
emergency FDA authorization for the test within 10 days of the rules
change, or within 10 days of notifying FDA of the intent to sell new
tests.
The FDA website had previously listed more than 200 companies that
intended to sell antibody tests, more than half of which were from
China. Some European countries had complained that certain Chinese
antibody tests were inaccurate.
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The FDA's list of tests no longer allowed on the market includes those from
vendors who voluntarily withdrew and those for which there is not a pending
request for the emergency use authorization, the agency said. (https://reut.rs/3cRSUYP)
Subsequent to the new guidance, Becton Dickinson and Co suspended distribution
of an antibody test they have been distributing since late March in partnership
with diagnostics company BioMedomics.
"BioMedomics has completed development of a second generation of the test...
[and] intends to submit a new EUA application to FDA once the second-generation
test has successfully completed all validation testing," Becton Dickinson said
last week in a statement.
(Reporting by Caroline Humer and Carl O'Donnell in New York and Manojna
Maddipatla in Bengaluru; Editing by Aditya Soni and David Gregorio)
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