THE US Food and Drug Administration has announced a new review pathway for consumer-facing genetic testing, saying the new technology presents "unique challenges to FDA regulation".
After a six month trial, the FDA has decided to implement a novel regulatory approach which allows genetic health risk (GHR) tests to be exempted from premarket review under certain conditions.
Certain tests which evaluate vitamin D levels and genetic carrier screening tests will also be exempted from premarket review - more details at www.fda.gov.
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