When does FDA require 522 postmarket surveillance?
Section 522 of the Federal Food, Drug and Cosmetic Act (the act) gives FDA the authority to require a manufacturer to conduct postmarket surveillance of a class II or class III device that meets any of the following criteria: • its failure would be reasonably likely to have serious adverse health consequences; • it is expected to have significant use in pediatric populations; • it is intended to be implanted in the body for more than one year; or • it is intended to be a life-sustaining or life-supporting device used outside a device user facility.
