Final Rule Declares LDTs 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 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.
Source: Drug Industry Daily