WASHINGTON, D.C. — The Food and Drug Administration (FDA) has updated its guidance regarding diagnostic tests for Highly Pathogenic Avian Influenza (HPAI). The new information can be found on the FDA’s Influenza Diagnostic Tests web page.
The update clarifies that Laboratory Developed Tests (LDTs) for HPAI, offered by clinical laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) and qualified to perform high-complexity testing, fall under the FDA’s general enforcement discretion approach. This means that these laboratories are not generally required to seek marketing authorization from the FDA before offering these tests.
The FDA’s stance is significant because it allows certified clinical laboratories to provide rapid diagnostic testing for HPAI without undergoing the lengthy process of FDA marketing authorization. This flexibility is crucial for timely and effective responses to potential avian flu outbreaks.
Currently, the FDA does not plan to issue Emergency Use Authorizations for in vitro diagnostics for HPAI. This decision is based on the lack of a relevant section 564 declaration, which would be necessary to issue such authorizations.
The FDA’s guidance aims to streamline the availability of critical diagnostic tools while ensuring that high standards of testing and laboratory certification are maintained. This approach is designed to balance regulatory oversight with the need for swift public health responses.
By allowing certified labs to operate under this discretion, the FDA is facilitating quicker access to essential diagnostic services, which is vital in managing and controlling outbreaks of HPAI.
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