Abstract
The regulatory path for biological products has been complex. The statutory definition and premarket jurisdiction over them have been criticized. The most recent significant attempt at reform for biological products (as well as for drugs and devices) was made under Section 16 of the Safe Medical Devices Act of 1990 and the subsequent FDA regulation and agreements between the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), the CBER and the Center for Devices and Radiological Health (CDRH), and the CDER and the CDRH. All drug-biological products, device-biological products, and drug-device combinations—as well as individual products—are assigned by primary mode of action as a biological product, drug, or device to the appropriate center charged with premarket review. In addition, the FDA has provided a product jurisdiction officer to make such an assignment if the status is unclear. However, the statutory definitions remain out of sync with the assignment of products to the centers and the effectiveness of this reform needs to be proven.
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