Hahn last week acknowledged that the FDA is relying on companies’ assurances that they verified their tests.
„What we’ve told manufacturers is that in order to market in the U.S., they have to validate their tests, they have to tell us that they validated their test, and then in the package insert they have to let people know — end users, labs, etc. — that those tests were not authorized by the FDA,“ he said at an April 24 coronavirus task force news briefing at the White House.
Hahn also told POLITICO the agency is considering revising its policy on the tests, attempting to balance quality with efforts to allow innovative products to reach consumers quickly in the midst of a crisis.
Krishnamoorthi’s decision to include BioMedomics in his inquiry puts a major U.S. health care firm in the spotlight. BioMedomics recently partnered with BD, one of the country’s largest medical tech manufacturers.
„The test does not require special equipment and may be used in a laboratory or at the point of care,“ the companies said in a March 31 announcement, adding, „Data on past exposure is important for researchers to more accurately understand the likely true occurrence of SARS-CoV-2 infection across a population. This information will be helpful in informing future strategies for combating COVID-19.“
David Lim contributed to this report.
Source: politico.com
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