LDT Final Rule Announced by the FDA

In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced its final rule declaring that in vitro diagnostic products (IVD) manufactured in a laboratory are now considered medical devices, and thus under the regulation of the FDA.

The FDA had proposed the rule last September. At the time, FDA Commissioner Robert Califf said, “A growing number of clinical diagnostic tests are being offered as laboratory-developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions.”

The FDA will host a webinar on May 14 to provide an overview of the final rule, including the phase-out policy. 

For expert insight into what the new rule means for test developers, join us for the FDAnews webinar, “FDA Oversight of Laboratory-Developed Tests.” Register here.

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