The FDA just changed how it reviews genetic health risk tests

From Engadget - November 6, 2017

The challenge for the FDA is ensuring the safety and accuracy of GHR tests while also making sure it's promoting and spurring innovation. "The agency has been increasingly nimble and creative in adapting its regulatory framework to fit the challenges of new technology platforms. In its consideration of GHR tests, the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight," said Gottlieb.

To do that, the FDA will now exempt GHR tests from premarket review as long as companies that are selling them meet certain requirements. From now on, manufacturers will have to present themselves to the FDA for a one-time review and if the agency finds that their practices are satisfactory and meet all of the necessary safety and reliability standards, they will be allowed to sell new GHR tests without any additional reviews. Until recently, consumers had to go to a physician in order to get the results of a genetic health risk test. The agency only began allowing popular at-home test-maker 23andMe to tell customers about certain health risks this April.


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