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AHA, Others Challenge FDA Move to Regulate lab-Developed Tests

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AHA, others request that the Food and Drug Administration withdraw the proposed draft guidance, Framework for Regulatory Oversight of Laboratory Developed Tests and associated guidance.

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Related Resources

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Early Disease Detection: 3 Tech Trends to Watch
Public
Advisory
FDA Issues Final Rule to Regulate Laboratory Developed Tests as Medical Devices
Member
Testimony
AHA Statement on "Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule."
Letter/Comment
AHA Letter to the FDA on Laboratory Developed Tests (LDTs) Proposed Rule
Letter/Comment
AHA to FDA Re: blood glucose monitoring test systems for prescription point of care use
Public
Laboratory Developed Tests (LDTs)

Related
News Articles

Court strikes down FDA rule on regulating lab-developed tests
Apr 1, 2025
FDA issues final rule applying medical device rules to laboratory developed tests 
Apr 29, 2024
AHA to Congress: FDA proposed rule for laboratory developed tests overreaches 
Apr 1, 2024
AHA to Congress: FDA proposal to regulate laboratory developed tests overreaches 
Mar 21, 2024
AHA comments on FDA proposed rule for laboratory developed tests
Dec 1, 2023
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