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 its concern that the proposed framework could mislead consumers about the validity of genetic tests.
Related:
- Comments submitted to FDA (January 2018)