This week, the Food and Drug Administration (FDA) stated said that it would take a fresh look at how they regulate truly novel medical advances. They want to make sure FDA is encouraging these developments and creating pathways that are risk-based, efficient, achieve the assurance of safety and efficacy, and in the case of tests, analytical and clinical validity, through a framework that is least burdensome.
With this backdrop, FDA Commissioner Scott Gottlieb, MD, announced that FDA was taking the steps to implement a novel regulatory approach for the regulation of genetic health risk (GHR) tests that applies oversight in a new, flexible way. On November 6, the FDA issued a notice of its intent to allow GHR tests to be exempted from premarket review under certain conditions. If and when this noticed is finalized, manufacturers of these types of tests would have to come to FDA for a one-time review to ensure that they meet FDA’s requirements, after which they may enter the market with new GHR tests without further review.
FDA will continue to look for opportunities to use this new regulatory approach, for both new tests and other novel medical products. Its goal is to streamline the regulatory pathway to get innovative medical products to people more efficiently, while providing the FDA assurances that consumers look for.