RAPS

DTC Genetic Health Risk Tests Exempted from FDA 510(k) Requirements

DTC Genetic Health Risk Tests Exempted from FDA 510 (k) Requirements Manufacturers of direct-to-consumer (DTC) genetic health risk (GHR) assessment systems were directed to withdraw pending 510 (k) ...
RAPS

FDA Announces Streamlined Review Pathway for DTC Genetic Tests

The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the ...
Healio

More than 50% of patients unaware of genetic testing for kidney disease

Please provide your email address to receive an email when new articles are posted on . More than half of National Kidney Foundation respondents were unaware of genetic testing opportunities. Only 9% ...