As of tomorrow, individual genetic risk tests are officially exempt from requiring 510(k) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test.
The notice, which will be officially published tomorrow , finalizes a guidance that was originally proposed in November 2017.
"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," FDA Commissioner Scott Gottlieb said in a statement at the time. "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."
In the new public rule, the FDA says it received one comment critical of the suggestion, from an unnamed industry group. The comment expressed a worry that, among other things, the new paradigm would allow companies to not only release comparatively unvetted tests to the public, but to falsely claim those tests are FDA-approved.
In response, FDA stresses in the document that companies offering genetic risk assessment tests will still need to meet the same standards as before, they just won't have to prove it before going to market. And companies making false claims will still be subject to FDA sanctions.
"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," the agency wrote. "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."
In addition, the exemption won't apply in the case of sufficiently high-risk genetic tests.
"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," the agency wrote.