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The new stipulates that so-called lab-developed tests will no longer require F.D.A. Authorization.
By Sheila Kaplan
Trump’s management ordered the Food and Drug Administration this week to authorize the use of some elegance of lab tests, some for coronavirus, first confirming that they work.
For months, some F.D.A. Officials are concerned that the pandemic will give clinics, educational establishments, and advertising labs an opportunity to get what they’ve been pushing for a long time: the flexibility to expand their own laboratory tests for F.D.A.-free diseases. Supervision. Wednesday has come true.
Some lawmakers are also concerned about change, especially a public fitness emergency when the need for accurate coronavirus testing is high. The F.D.A. required it to provide emergency authorizations for laboratory-developed tests in other outbreaks.
The announcement “is deeply troubling and suggests that Trump’s management has re-interfered with the FDA in medical products,” New Jersey’s New Jersey representative, chairman of the House’s Energy and Commerce Committee, said in a statement.
“I don’t think the time has come to decrease COVID-19 monitoring,” he said.
While the maximum and non-unusual laboratory tests are advertising tests, manufactured and advertised in several laboratories, other tests are developed and validated in a specific laboratory. These tests, called “lab-evolved tests” or LDTs, are used only in this lab and are sometimes not distributed or sold to other laboratories or fitness centers, some paints with samples sent by mail.
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