Who is the responsible party for a pediatric postmarket surveillance of a device product that is not a clinical trial?

For a pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party would be considered the entity FDA, under section 522 of the FD&C Act, orders to conduct the pediatric postmarket surveillance of a device product. [42 CFR 11.4(c), 11.10(a); 81 FR 65003].