1. A medical or surgical procedure performed using an approved device, drug, or technique in a manner not specified in its official labeling or approval; use of a medical intervention for purposes, populations, or dosages other than those approved by regulatory authorities
The surgeon performed an off-label procedure using the approved device in a novel way to treat the patient's rare condition.
O cirurgião realizou um procedimento fora da indicação, utilizando o dispositivo aprovado de uma forma inovadora para tratar a condição rara do paciente.