As of June 5, the Food & Drug Administration (FDA) officially made genetic risk assessments exempt from 501(k) premarket approval, as long as the company providing the test has gone through a one-time premarket review of its testing apparatus and at least one test, as reported by Jonah Comstock in Mobile Health News. Officially published in the Federal Registry, the notice finalized a guidance that was originally proposed in November 2017.
In November, FDA Commissioner Scott Gottlieb said, "Today, the FDA is taking steps to implement a novel regulatory approach for the regulation of GHR tests that applies proper oversight in a flexible, new way. It builds on the important lessons we learned from the FDA’s authorization of the first GHR and carrier screening tests sold directly to consumers."
The FDA summarized, “This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.” However, the agency assured the public that it would address genetic health risks during the approval process.
Between the proposal of the regulation and the release of the guidance document, the FDA received one comment that was critical of the concept. The comment, which came from an unnamed industry group, stated a concern that the new ruling would enable companies to release relatively unvetted tests to the public, as well as to improperly claim that the tests have FDA approval.
To respond to that concern, the FDA was emphatic about the fact that companies that provide genetic risk assessment tests will continue to have to meet the same standards as they did previously. The ruling will simply exempt them from proving it before going to market. Additionally, companies that make false claims will continue to be subject to FDA sanctions, and the exemption will not apply in the case of sufficiently high-risk genetic tests.
The FDA concluded, "In summary, all tests that are marketed under this classification regulation must meet the general controls and the special controls that are specified in the regulation. Ability of a manufacturer to meet these special controls is demonstrated during the one-time review. Even after the one-time review, the general controls and special controls must continue to be met, including for all tests added or modified after the one-time review of a manufacturer’s device. FDA’s exemption from 510(k) for class II devices listed in table 1 applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality."