Risk to health

This definition decides whether a correction or removal has to be reported to FDA. It covers temporary or medically reversible outcomes as well as serious ones, so it reaches well beyond the most severe cases.

Risk to health means (1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or (2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.

21 CFR, 806.2