Laboratory Question for the Week of May 6, 2019

Laboratory Compliance Question of the Week

Question:

I have heard that the FDA will begin to regulate lab-developed tests (LDTs). Can you provide any information about this?

Answer:

Recently, Congress has issued bipartisan draft legislation referred to as the Verifying Accurate, Leading-edge In Vitro Clinical Test Development (VALID) Act, which has stirred up some controversy among industry associations. This bill details the framework for the Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) for in vitro clinical tests (IVCTs). The latest version added major ideas from the FDA such as a precertification program for both areas.


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