January 2018

Advancing Evidence-Based Genetic Testing

Advancing Evidence-Based Genetic Testing

In 2018, the U.S. Food and Drug Administration (FDA) invited comments on its intention to exempt a list of class II devices from premarket notification requirements, including tests assessing genetic health risks. ASHG responded to this request for comment by outlining its support for regulation that brings scientifically valid, evidence-based tests to market, and expressing... Read More

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