Package Inserts/Instructions for Use (IFU) definition
Package Inserts/Instructions for Use (IFU) means information supplied by the manufacturer of a product that includes all the information needed for use of the Product as intended including all authorized labeling and Fact Sheets, operating instructions, warnings and/or precautions, indications, contraindications, information relative to sterilization, instructions in the event of damage to sterile packaging, cleaning, disinfection information, etc.
Package Inserts/Instructions for Use (IFU) means information supplied by the manufacturer of an implant or product that includes all the information needed to use it safely. Specifications for Package Insert/IFU content vary with regulatory jurisdiction, but typically include operating instructions, warnings and/or precautions, indications, contraindications, information relative to sterilization, instructions in the event of damage to sterile packaging, cleaning, disinfection information, etc. The Package Insert/IFU must accompany the implant or product in most jurisdictions, except in the U.S. where electronic provision is an alternative.