The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' The intent of this draft guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. This draft guidance is not final nor is it in effect at this time.
Document
Utilizing Animal Studies To Evaluate Organ Preservation Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices....
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Federal Register Citation
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82 FR 43390
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“Utilizing Animal Studies To Evaluate Organ Preservation Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (September 15, 2017), https://thefederalregister.org/documents/2017-19613/utilizing-animal-studies-to-evaluate-organ-preservation-devices-draft-guidance-for-industry-and-food-and-drug-administra.