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What does the FDA expect to see in your Health Hazard evaluation (HHE)?

First, it is important to note that you need to conduct a Health Hazard Evaluation if you are either recalling or need to evaluate whether or not to recall.

The elements need the following elements:

(1) Whether any disease or injuries have already occurred from the use of the product.

(2) Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard. Any conclusion shall be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination.

(3) Assessment of hazard to various segments of the population, e.g., children, surgical patients, pets, livestock, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk.

(4) Assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed.

(5) Assessment of the likelihood of occurrence of the hazard.

(6) Assessment of the consequences (immediate or long-range) of occurrence of the hazard.

 A few things about Health Hazard Evaluation (HHE)

• May be updated as situation unfolds

• May incorporate information from manufacturer, pre-market submissions, MDR’s, complaints by users, scientific information, literature

• Is used to classify recalls

• Guides FDA enforcement actions

For more information related to this checkout this FDA webpage: