The Food and Drug Administration will soon directly regulate some genetic diagnostic tests.

The FDA will publish a draft guidance to guide laboratories through the process of notifying the FDA that they are developing or utilizing lab-developed tests, informing the FDA about said tests, and complying with medical device reporting requirements.

The news release is available here.

This is a new area of regulation for the FDA and could cover more than 11,000 tests developed by about 2,000 different laboratories.

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