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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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Unpacking Averages: Assessing the Products Included in FDA s Voluntary Malfunction Summary Reporting Program | Epstein Becker & Green

Unpacking Averages: Assessing the Products Included in FDA s Voluntary Malfunction Summary Reporting Program | Epstein Becker & Green
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FDA Finalizes LDT Regulation, With Significant Exceptions: Enforcement Of Requirements Will Phase In Over Four Years - Healthcare

FDA Finalizes LDT Regulation, With Significant Exceptions: Enforcement Of Requirements Will Phase In Over Four Years - Healthcare
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Reviewing FDA VSMR Manufacturer Draft Guidance

Reviewing FDA VSMR Manufacturer Draft Guidance
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Program product codesMalfunction summary reporting programProgram for manufacturersVoluntary malfunction summary reportingMedical device user fee amendmentsCommitment letterMalfunction summary reportingProgram productVoluntary malfunction summary reporting programFederal registerGood guidance practicesProduct classification database