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A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs

The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more

Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care [Video]

Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing. We've covered reimbursement...more

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more

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