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 ...
JD Supra

Top Considerations for Setting up Direct-to-Consumer Laboratory Testing Services

The direct-to-consumer (DTC) laboratory testing landscape is rapidly evolving, and the opportunities are significant. As more states open the door to DTC laboratory testing, laboratories, digital ...
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) ...
Wellbeing Magazine on MSN

How direct-to-consumer laboratories can improve the patient experience

Direct-to-consumer (DTC) laboratory testing has changed how people think about their health data. Patients no longer wait for ...