Gene-Testing Companies May Need FDA Device Review
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Interleukin Genetics Inc. and CyGene Laboratories Inc. are among 13 makers of genetic tests sold directly to consumers told by U.S. regulators that their products may be medical devices needing federal approval.
The U.S. Food and Drug Administration sent letters to the companies saying the tests “appear to meet the definition of a device.” Interleukin doesn’t believe its tests are devices and will provide information to regulators to support its position, the Waltham, Massachusetts-based company said today in a regulatory filing.