In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk direct-to-consumer genetic risk tests.
Under the new policy, Genetic Health Risk (GHR) tests will be exempt from premarket review under certain conditions. If and when the policy is finalized, manufacturers of these types of tests would receive a one-time review to ensure that they meet the FDA's requirements, after which they may enter the market with new GHR tests without further review. The agency also established special controls for these tests in a separate order, which outline requirements for assuring the tests' accuracy, reliability and clinical relevance and describe the type of studies and data required to demonstrate performance of certain types of genetic tests.
In a blog post announcing the new policy, Gottlieb noted the importance of GHR tests to help people gain insight into their predisposition to certain illnesses or diseases. He also pointed out that more and more of these tests are being developed and marketed to consumers directly. While this could provide consumers access to more information, he said, FDA regulation is needed to ensure the quality of the tests. Gottlieb said that with the new policy "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."
In addition, Gottlieb announced that FDA has classified certain tests to evaluate vitamin D levels in class II, subject to special controls, and announced its intent to exempt these tests from premarket review. Finally, the FDA issued a final order exempting genetic carrier screening tests from premarket review.
This regulatory approach continues the FDA's efforts to streamline and in some cases reduce regulation for digital health technologies. It is similar to the proposed manufacturer-based, pre-certification model developed for other digital health technologies launched by FDA earlier this year. Under that program, the developers of medical software receive FDA certification of fitness and not the products themselves. Gottlieb said that FDA will keep looking for ways to use this regulatory model for new tests and novel technologies.