Final Rule Declares IVDs to Be Devices Regulated 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 a final rule declaring that in vitro diagnostic products (IVD) are now considered medical devices, and thus under the regulation of the FDA.
Source: Drug Industry Daily