Responsible Off-Label Device Use in Surgical Innovation: A Review and LABEL Framework
Published online on July 31, 2026
Abstract
Surgical Innovation, Ahead of Print.
BackgroundOff-label and Instructions-for-Use (IFU)-silent medical-device use is common in surgery. Such use is not inherently unsafe, unethical, or unlawful. However, it raises important questions about evidence, consent, professional judgement, ...
BackgroundOff-label and Instructions-for-Use (IFU)-silent medical-device use is common in surgery. Such use is not inherently unsafe, unethical, or unlawful. However, it raises important questions about evidence, consent, professional judgement, ...