FDA to oversee genetic and other lab tests

| | Health Imaging | Molecular Imaging

The FDA has announced that more than 11,000 lab-driven diagnostic tests that have never been regulated will now fall under the agency's oversight. This includes cancer screening and genetic testing, an area of research that has exploded in the past couple of decades.

A new regulatory system has been outlined in guidelines that are making their way through U.S. Congress. “Just as drugs need to be safe and effective for treating diseases, medical devices used to help diagnose disease and direct therapy also need to be safe and effective. These devices need to be accurate and reliable.,” Margaret Hamburg, the FDA Commissioner, reportedly said in a conference call.

FDA to regulate thousands of cancer, genetic, and other diagnostics via Forbes

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