genetic risk assessment test

By Jonah Comstock June 4, 2018
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 in the Federal Registry, finalizes a guidance that was originally proposed in November 2017. "Today,...
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