Glossary Term
On-label Use
Definition
On-label use refers to the use of a medical device, drug, or treatment in a manner that is consistent with the indications, dosages, and patient populations approved by regulatory agencies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). When a product is used on-label, it means that the treatment is being used in accordance with the conditions specified in the product’s approved labeling and regulatory approval.
Relevance to the MedTech Industry
On-label use ensures that a medical device or pharmaceutical product is used as intended by the manufacturer, with its safety and efficacy supported by the clinical data submitted during the regulatory approval process. By adhering to on-label use, healthcare professionals can have greater confidence in the treatment’s effectiveness and minimize risks to patients. On-label use is also important for regulatory compliance, as it aligns with the conditions for which the product was approved.
Additional Information & Related Terms
Related Terms
Off-Label Use: The use of a medical device or drug for indications or populations that have not been approved by regulatory agencies, which can carry legal and safety risks.
Regulatory Approval: The process by which a medical device or drug is reviewed and authorized by regulatory agencies (e.g., FDA, EMA) for specific indications and uses.
Clinical Trials: Research studies designed to demonstrate the safety and efficacy of medical devices or drugs for on-label uses before regulatory approval.
Indications for Use: The specific medical conditions, diseases, or symptoms that a medical device or drug is intended to treat, as outlined in its regulatory approval.