GLOSSARYUS
Risk to Health
Under 21 CFR Part 806, the hazard level that triggers reporting of a correction or removal. Two cases qualify. One is a reasonable probability of serious adverse health consequences or death. The other is a possibility of temporary or medically reversible consequences, or of an outcome where serious consequences are remote.
Avoid This Mistake
Risk to health is wider than serious harm: the Part 806 definition also reaches outcomes where the probability of serious adverse health consequences is remote.