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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.

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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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FDA Warning Letter Is A Stark Reminder That If You Claim Your Product Is RUO, It Has To Be RUO - Healthcare

In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates.

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FDA Reminds Producers on Vitality of Research Use Only Products

FDA Reminds Producers on Vitality of Research Use Only Products
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