Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action?

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action?

• A. CDER
• B. CBER
• C. CDRH
• D. OCP

Answer: (C)

The primary jurisdiction for a vascular graft that includes an antibiotic component based on its primary mode of action would be with the Center for Devices and Radiological Health (CDRH). This is because the primary function of the product relates to its use as a medical device. In this context, a vascular graft is designed to replace or support blood vessels, which categorically falls within the realm of medical devices as regulated by CDRH. Moreover, even though the graft includes an antibiotic, which is a drug component, the primary classification of the graft itself is a device. According to FDA regulations, when a product has both device and drug components, the determination of jurisdiction focuses on the primary mode of action. In this case, the vascular graft's function as a device is paramount, along with the antibiotic acting as an adjunct to enhance its effectiveness or to prevent infection. This jurisdictional nuance illustrates how the FDA assesses products that involve both drugs and devices: they focus on the primary purpose of the product when assigning regulatory oversight. Hence, the correct answer specifically aligns with the understanding that CDRH is responsible for overseeing medical devices, including those that may have additional drug-like characteristics.

The primary jurisdiction for a vascular graft that includes an antibiotic component based on its primary mode of action would be with the Center for Devices and Radiological Health (CDRH). This is because the primary function of the product relates to its use as a medical device.

In this context, a vascular graft is designed to replace or support blood vessels, which categorically falls within the realm of medical devices as regulated by CDRH. Moreover, even though the graft includes an antibiotic, which is a drug component, the primary classification of the graft itself is a device. According to FDA regulations, when a product has both device and drug components, the determination of jurisdiction focuses on the primary mode of action. In this case, the vascular graft's function as a device is paramount, along with the antibiotic acting as an adjunct to enhance its effectiveness or to prevent infection.

This jurisdictional nuance illustrates how the FDA assesses products that involve both drugs and devices: they focus on the primary purpose of the product when assigning regulatory oversight. Hence, the correct answer specifically aligns with the understanding that CDRH is responsible for overseeing medical devices, including those that may have additional drug-like characteristics.