What is a "legend device" in pharmaceuticals?

A "legend device" in pharmaceuticals refers to a device that contains a legend drug, which is a medication that can only be dispensed with a prescription. Devices like auto-injectors and transdermal patches fall under this category because they deliver medications that are classified as legend drugs. These devices are regulated to ensure they are used safely and effectively when prescribed by a licensed healthcare provider.

Understanding that legend drugs require a prescription is crucial because it emphasizes the importance of oversight in their use. Devices classified as legend must meet specific regulatory standards to ensure they provide the intended therapeutic benefit without posing undue risk to patients. This context helps clarify why devices associated with legend drugs, rather than those used solely for research or classified as durable medical equipment, define what constitutes a "legend device."