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This guidance explains how the approval process applies to heritable intentional genomic alterations (IGA) in animals.  

IGAs in animals are intentional genomic alterations made using modern molecular technologies, may include random or targeted DNA sequence changes, including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal.

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Translation

This FDA guidance is intended to clarify our requirements and recommendations for developers of IGAs in animals.

In order to make FDA guidance regarding IGAs in animals clearer and more streamlined, and to allow for a process to update the more technical portions of our guidance, this guidance has two parts:

• GFI #187A, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach,“ articulates our risk-based approach to the oversight of heritable IGAs in animals. The guidance explains that FDA’s approach is risk-based and ranges from:  Category 1 products for which we do not expect developers to consult with us prior to marketing an animal containing an IGA; to Category 2 products for which we may not expect developers to submit an application for approval of the IGA if, after looking at data submitted about that product’s risk, we find that we understand the product’s risks for the specified intended use, any identified risks are appropriately mitigated, and we have no further questions for which we would need to see additional data to address; to Category 3 products for which FDA will review and, where the data supports it, approve a product using data requirements that are proportionate to the risk associated with the particular product; and
• GFI #187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process,” provides technical guidance for those IGAs in animals that go through the approval process.  This guidance is applicable once a sponsor is submitting an application for approval for IGAs described as Category 3 in GFI #187A or for those in Category 2 for which FDA has determined that it does not intend to exercise enforcement discretion over the approval requirement.  

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