Risk to health

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.

Source

21 CFR § 806.2


Scoping language

As used in this part:

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