FDA Announces Intention to Regulate LDTs as Devices

Jeff Gibbs authored and article “FDA Announces Intention to Regulate LDTs as Devices” for Genetic Engineering & Biotechnology News

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).

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