An Overview of the FDA Approval Process for Devices

Martha Murray, MD, MS, FAAOS; Jonathan Dubin, MD, FAAOS

In 1976, Congress passed the Medical Device Amendments Act, which granted the Food and Drug Administration (FDA) authority to regulate medical devices. Within the FDA, the Center for Devices and Radiological Health (CDRH) typically oversees the process; however, if a device includes a biologic component, the Center for Biologics Evaluation and Research may oversee its evaluation. At present, the CDRH regulates