Glossary Term
Instructions for Use (IFU)
Definition
Instructions for Use (IFU) are comprehensive documents that accompany medical devices, providing users with detailed information on the safe and effective use, maintenance, storage, and disposal of the product. IFUs are a regulatory requirement and must be written clearly, addressing both healthcare professionals and, where applicable, laypersons.
Relevance to the MedTech Industry
IFUs ensure that medical devices are used correctly and safely, minimizing the risk of harm to patients or users and enhancing device performance. They serve as a key communication tool between manufacturers and end-users, ensuring regulatory compliance and fostering user confidence in the device.
Additional Information & Related Terms
Related Terms
Labeling Requirements: Regulatory guidelines that encompass IFUs as part of device labeling.
Human Factors Engineering (HFE): Ensures IFUs are intuitive and address user needs effectively.
Post-Market Surveillance (PMS): Feedback from real-world device use may prompt updates to IFUs.
Usability Testing: A process to validate the clarity and effectiveness of IFUs.