On July 22, the FDA announced an update to the Influenza Diagnostic Tests webpage, indicating that LDTs for Highly Pathogenic Avian Influenza (HPAI) offered by clinical laboratories that are certified under Clinical Laboratory Improvement Amendments (CLIA) and qualified to perform high-complexity testing currently fall under the FDA’s general enforcement discretion approach for LDTs.
The FDA generally does not expect clinical laboratories that are certified under CLIA and qualified to perform high-complexity testing to request marketing authorization from the FDA for their LDTs for HPAI prior to them offering those LDTs. The FDA would not issue Emergency Use Authorizations for such in vitro diagnostics given that there is no relevant section 564 declaration.
