Glossary Term
Labeling For Investigational Devices
Definition
Labeling for investigational devices refers to the specific regulatory requirements governing the information displayed on medical devices used in clinical trials or other investigational settings. These labels must clearly indicate that the device is for investigational use only and comply with guidelines set by regulatory authorities, such as the FDA or the European Medicines Agency (EMA).
Relevance to the MedTech Industry
Labeling for investigational devices ensures transparency, proper handling, and ethical use during clinical studies. It helps protect patient safety, informs investigators of the device's intended use, and ensures compliance with regulations that govern investigational trials.
Additional Information & Related Terms
Examples of Labeling Requirements for Investigational Devices
FDA (21 CFR 812.5): Labels must include the statement: "CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use."
EU MDR (Article 62): Labels must indicate investigational status, include the Clinical Investigation Plan (CIP) number, and provide multilingual warnings.
Related Terms
Investigational Device Exemption (IDE): FDA authorization allowing investigational devices to be used in clinical studies.
Clinical Trial Materials (CTM): Supplies, including labeled devices, used in clinical investigations.
Post-Market Transition: Labeling updates to reflect commercial availability after regulatory approval.
Regulatory Compliance: Adherence to local and international labeling laws for investigational use.
Study Protocol: A document guiding investigational use, often linked to labeling content.