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FDA Guidance Documents and Implementation Instructions

Licensed blood establishments planning to implement a new version of the DHQ materials that has not been officially recognized by the FDA must submit a formal request to the FDA for approval. The facility should call its Consumer Safety Officer for the proper reporting category.

Version 2.0 DHQ, aDHQ and Accompanying Materials

To view this guidance on FDA’s Blood Guidances web page, click here.

Version 1.3

Licensed blood establishments planning to implement a new version of the DHQ materials that has not been officially recognized by the FDA must submit a formal request to the FDA for approval. The facility should call its Consumer Safety Officer for the proper reporting category.