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 division that would have primary jurisdiction over a vascular graft with an antibiotic based on its primary mode of action is indeed the Center for Devices and Radiological Health (CDRH). This center within the U.S. Food and Drug Administration (FDA) is responsible for the regulation of medical devices, including surgical implants like vascular grafts. Vascular grafts are classified as medical devices because they are intended to be used in a medical context to replace or support blood vessels. The addition of an antibiotic as a part of the graft's structure does not change its primary classification as a medical device but rather serves to enhance its performance by reducing the risk of infection, which is a significant concern in surgical applications. The jurisdiction of the CDRH encompasses a wide range of medical devices. While the Center for Drug Evaluation and Research (CDER) focuses on pharmaceuticals and drug products, and the Center for Biologics Evaluation and Research (CBER) oversees biological products, the CDRH is the suitable regulatory body for a device like a vascular graft, regardless of any incorporated antimicrobial properties. The Office of Combination Products (OCP) is responsible for overseeing products that combine elements of drugs and devices but in this case, since the primary mode of action relates primarily to

The division that would have primary jurisdiction over a vascular graft with an antibiotic based on its primary mode of action is indeed the Center for Devices and Radiological Health (CDRH). This center within the U.S. Food and Drug Administration (FDA) is responsible for the regulation of medical devices, including surgical implants like vascular grafts.

Vascular grafts are classified as medical devices because they are intended to be used in a medical context to replace or support blood vessels. The addition of an antibiotic as a part of the graft's structure does not change its primary classification as a medical device but rather serves to enhance its performance by reducing the risk of infection, which is a significant concern in surgical applications.

The jurisdiction of the CDRH encompasses a wide range of medical devices. While the Center for Drug Evaluation and Research (CDER) focuses on pharmaceuticals and drug products, and the Center for Biologics Evaluation and Research (CBER) oversees biological products, the CDRH is the suitable regulatory body for a device like a vascular graft, regardless of any incorporated antimicrobial properties. The Office of Combination Products (OCP) is responsible for overseeing products that combine elements of drugs and devices but in this case, since the primary mode of action relates primarily to