Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency." This draft guidance, when finalized, will describe the factors FDA intends to assess when deciding to issue an enforcement policy regarding test manufacturers' offering of certain unapproved tests and unapproved uses of approved tests during a declared emergency. This draft guidance is not final nor is it for implementation at this time.
Abstract as published in the Federal Register.
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