Tens of thousands of medical tests to now fall under federal oversight

The Hill ^ | 04/29/2024 | JOSEPH CHOI

[ChicagoConservative27]

The Food and Drug Administration (FDA) is revising long-standing rules to place laboratory tests under the same jurisdiction as other testing, which the agency says will help ensure better safety and efficacy.

Since 1976, the FDA has not enforced legal requirements on most laboratory developed tests (LDT) due to the Medical Device Amendments. Generally speaking, this has meant that requirements such as good manufacturing practices, premarket reviews prior to use in patients and adverse event reporting has not been enforced.

LDTs are diagnostic tests that are made and used within a single laboratory. As the FDA noted in its rule Monday, LDTs were typically manufactured in small volumes to diagnose rare diseases. At the time, the FDA’s rationale for not enforcing regulations on these tests were that they were low-risk and were employed for a small patient population.

[ransomnote]

The FDA was aware that they were using a PCR 'test' that was not appropriate for diagnosing illness, according to its inventor, and that the PCR was not based on the actual Covid19 virus, and was instead based on a 'related corona virus'. Even that last phrase is a problem because the CDC classified Covid as 'novel' and told us that meant it was entirely new to our immune system so how could there be a 'related coronav virus' worth using as a test for Covid?

The FDA was fine with the PCR, and when, according to Dr. Birx (circa 2020), "We don't have flu anymore" the FDA never connected the dots -testing a related Corona Virus identified many seasonal flu viruses that WERE related to the virus used for the PCR reference sample.

[dadfly]

outrageous. more big med/gov’t tyranny.

[DoughtyOne]

T O T A L . C O N T R O L

It’s 1937 Germany on display in America, and Trump isn’t
president.