Post-Market
Health Hazard Evaluation(HHE)
In one line
Structured assessment of patient/user risk used to support recall classification and field-action decisions.
Definition
An HHE evaluates the disease/condition affected, severity of consequence, probability of occurrence, exposed population, and mitigations. The output supports recall classification (I/II/III) and the urgency of customer notification.
HHEs are usually done by a cross-functional team, including clinical or medical input, and should be based on facts from complaints, investigations and risk management files. The conclusions decide whether an action is a recall, its classification and the depth of notification. FDA performs its own health hazard evaluation when classifying a recall, and differences from the firm's view can lead to a higher class.
Why it matters
FDA recall coordinators frequently require an updated HHE during recall negotiation; pre-built templates accelerate response.
Common pitfalls
- •Failing to update an HHE when new information or complaints emerge can lead to an incorrect recall classification.
- •Underestimating the severity of a health consequence can result in an inadequate recall strategy.
- •Not clearly documenting the HHE methodology and conclusions can lead to regulatory scrutiny.
- •Confusing a health hazard evaluation with a routine risk assessment can misdirect post-market activities.
- •Delaying the completion of an HHE can prolong patient exposure to hazardous products and worsen regulatory outcomes.
Sources
- 21 CFR Part 7, Recalls · FDA
- EUDAMED Public Site · European Commission
- MDCG Vigilance Guidance · MDCG