FDA Action on Clinical Diagnostics Poised to Gain Steam in 2023 (1)

The FDA will likely rekindle its efforts to oversee diagnostic tests from laboratories after lawmakers failed to act on legislation requiring the agency to regulate them, former Food and Drug Administration officials and policy analysts say.

The agency now is likely to give itself clear authority to oversee tests regardless of whether they came from clinical laboratories or commercial companies. Congress had been considering attaching The Verifying Accurate Leading-Edge IVCT Development, or VALID, Act to the fiscal 2023 omnibus spending package, but it was left out of the final agreement.

Now, without FDA action, patients will be left with uncertainty ...