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Device-Led Combination Product

Meaning

A Device-Led Combination Product is a therapeutic or diagnostic product composed of two or more regulated components, such as a medical device and a drug or biological product, where the primary intended action is provided by the device component. In the hormonal health space, this could include a continuous glucose monitor coated with a localized drug delivery component or a sophisticated hormone delivery pump. The regulatory classification as “device-led” means the primary review authority, like the FDA’s Center for Devices and Radiological Health (CDRH), focuses predominantly on the device’s safety and effectiveness. This classification streamlines the regulatory process for complex products.