2025-18402: Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency." This guidance describes the factors FDA intends to assess in deciding whether to issue an enforcement policy regarding in vitro diagnostic test manufacturers' offering of certain unapproved in vitro diagnostic tests and unapproved uses of approved in vitro diagnostic tests during a declared emergency.
The agency’s own summary, as published.
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