FDA Announces Intention to Regulate LDTs as Devices

September 10, 2014
FDA Announces Intention to Regulate LDTs as Devices
With the issuance of this new framework, the debate over FDA regulation of LDTs is now going to be held in full public view. [© Alexander Raths - Fotolia.com]

Jeffrey N. Gibbs

In 1992, the Food and Drug Administration (FDA) first stated that it had authority to regulate laboratory-developed tests. On July 31, FDA took its biggest step toward invoking this asserted authority by unveiling its “Framework for Regulatory Oversight of Laboratory-Developed Tests (LDTs).”

In the framework, FDA explains that while it had traditionally exercised enforcement discretion and not regulated LDTs, due to changes in the role and type of LDTs, the agency now intends to regulate LDTs as devices. The agency plans to do this in stages, phased in over a lengthy period of time.

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