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United States - Healthcare - FDA Finalizes Rule And Sets Course To Phase In Oversight Of Laboratory Developed Tests

FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | Goodwin

United States - Healthcare - What You Should Know About The FDA s New Final Rule On LDTs

On May 6, 2024, the FDA published its highly anticipated final rule, which was formally published in the Federal Register on May 6, revising the regulatory definition of an IVD product to explicitly capture IVDs manufactured by laboratories.

What You Should Know About The FDA s New Final Rule On LDTs

What You Should Know About The FDA s New Final Rule On LDTs
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