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

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

Published: May 22, 2024

On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs)...

Source: mondaq.com
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United States - Healthcare - What You Should Know About The FDA's New Final Rule On LDTs - Vimarsana News

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

Published: May 20, 2024

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.

Source: mondaq.com
Related Topics:
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