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FDA's Regulatory Moves

The US Food and Drug Administration has been taking some steps lately to regulate genetic and genomic in vitro diagnostic devices "in a risk-based and scientifically driven manner" that will enable personalized medicine, writes Joanne Hawana at The National Law Review.

This year, Hawana writes, FDA authorized the marketing of 23andMe's autosomal carrier screening gene mutation test for Bloom Syndrome, which the company submitted as a de novo classification request. FDA concluded that the test should be regulated as Class II, subject to special controls.

Further, Hawana writes that FDA's review of 23andMe's data and its decision on the regulation of the test led the agency to issue two orders regarding autosomal recessive carrier screening gene mutation detection systems in general: First, it classified this type of device as Class II with special controls and exempted it from premarket notification requirements.

These special controls cover access to genetic counseling services, specimen collection devices, warning statements, and limits on distribution, among others. That limit on distribution means, she adds, that only the test manufacturer, its subsidiaries, and CLIA-regulated clinical laboratories may distribute such tests.

"Many of FDA's public health concerns about the widespread availability of direct-to-consumer genetic tests through outlets such as … would be mitigated by these distribution limits and other special controls for the device," Hawana says. "As other types of genetic and genomic test systems receive FDA's blessing, we expect to see similar controls established to ensure safety and effectiveness."