publication date: Oct. 3, 2014


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FDA Publishes Two Draft Guidances for Lab-Developed Tests

By Matthew Bin Han Ong

FDA published two draft guidance documents Oct. 3 for regulatory oversight, notification and medical device reporting for laboratory developed tests.

LDTs are a category of assays that has escaped scrutiny because of loopholes in the regulatory process—laboratories can get around FDA measures of analytic validity, clinical validity and clinical utility using LDTs.

FDA has been phasing in regulation of LDTs, starting with assays that may lead patients to select one treatment option over others (The Cancer Letter, Aug. 1).

According to the new draft guidances, the FDA oversight framework would require notifying FDA of all LDTs manufactured by a laboratory. All clinical laboratories manufacturing LDTs for clinical use would be required as medical device manufacturers to submit reports to the FDA if malfunctions or adverse events occur.

FDA also intends to continue exercising enforcement discretion with respect to applicable premarket review requirements and quality system requirements for Class I devices, which present the lowest risk.

The Federal Register notices for these draft guidances are currently available here and here.

“As a general matter, FDA proposes a risk-based, phased-in approach, in combination with continued exercise of enforcement discretion for certain regulatory requirements and certain types of LDTs,” the agency wrote in the regulatory oversight draft guidance.

“First, FDA believes that the health risks associated with LDTs, as with all [in vitro diagnostic devices], vary with each type of device and the Agency’s regulatory activities should, accordingly, be implemented based on risk.

“Second, a phased-in implementation period … Continue reading 40-37 FDA Publishes Two Guidances for Lab-Developed Tests

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