Risk to Health [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 806.2 (j) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter H Medical Devices; Part 806 Medical Devices; Reports of Corrections and Removals; Subpart A General Provisions], the term "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.”