FDA to Omit 501(k) Premarket Approval for Genetic Risk Tests

June 5, 2018  Source: MobiHealthNews 229

The notice will be officially published in the Federal Registry, finalize a guidance that was actually proposed in November 2017.

Scott Gottlieb FDA Commissioner said, “FDA is taking steps to enact a novel regulatory approach for the rule of GHR tests that applies error in a flexible, new way. It builds on the important lessons we cultivated from the FDA’s authorization of the first GHR and carrier screening tests sold directly to customers."

The FDA also mentioned, companies providing (GHR) genetic risk assessment tests have to meet the same standards as before. And companies making false profess will still be subject to FDA sanctions. In addition, the exemption won't apply in the case of adequately high-risk genetic tests.

"The FDA’s exemption from 510(k) for class II devices listed in table 1 applies only to those devices that have existing or reasonably predictable quality of commercially distributed devices within that generic type, or, in the case of IVD (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 FDA wrote.

By Ddu