CDRH Orders DTC Genetic Health Risk Test Manufacturers to Withdraw 510(k) Applications

The FDA told manufacturers of direct-to-consumer genetic health risk (GHR) assessment systems to withdraw pending 510(k) applications, as the devices are now exempt from premarket notification.

The exemptions for DTC genetic tests, as well as other four other devices that include 25-hydroxyvitamin D mass spectrometry test systems and endoscope disinfectant basins, were put in place to reduce regulatory burdens on the medical device industry, the FDA said.

The affected firms now only need to undergo a one-time regulatory review before entering the U.S. market.