FDA Lifts Some Regulatory Hurdles for Genetic Health Risk Tests as Planned

The US Food and Drug Administration lifted some regulatory hurdles for makers of direct-to-consumer genetic health risk tests. After obtaining a first premarket authorization for a genetic health risk (GHR) test, manufacturers can now commercialize new tests without additional review.

Source: https://www.genomeweb.com/molecular-diagnostics/fda-lifts-some-regulatory-hurdles-genetic-health-risk-tests-planned