FDA Center for Devices and Radiological Health

U.S. government agency responsible for medical devices and radiological health

FDA Building 62 Exterior

The FDA Center for Devices and Radiological Health (CDRH) is a branch of the United States Food and Drug Administration (FDA), which is part of the United States Department of Health and Human Services. The CDRH is responsible for ensuring the safety and effectiveness of medical devices and the safety of radiation-emitting products.

Overview

The CDRH is tasked with the regulation of medical devices ranging from simple items like tongue depressors to complex technologies such as pacemakers. It also oversees the safety of radiation-emitting electronic products such as X-ray machines, microwave ovens, and laser equipment.

Functions

The primary functions of the CDRH include:

• Premarket Approval: The CDRH evaluates new medical devices before they can be marketed in the United States. This involves reviewing clinical data to ensure that the devices are safe and effective for their intended use.

• Postmarket Surveillance: After a device is on the market, the CDRH monitors its performance to identify any potential safety issues. This includes analyzing adverse event reports and conducting inspections of manufacturing facilities.

• Compliance and Enforcement: The CDRH ensures that manufacturers comply with regulatory requirements. It has the authority to take enforcement actions, such as issuing warning letters or seizing products, if necessary.

• Radiological Health: The CDRH sets standards for radiation-emitting products to protect public health. It conducts research and provides guidance on the safe use of these products.

Organizational Structure

The CDRH is organized into several offices, each with specific responsibilities:

• Office of Device Evaluation (ODE): Responsible for the premarket review of medical devices.

• Office of Compliance (OC): Ensures that medical devices comply with regulatory requirements.

• Office of Surveillance and Biometrics (OSB): Monitors the safety and effectiveness of medical devices after they are on the market.

• Office of Science and Engineering Laboratories (OSEL): Conducts research to support the regulatory mission of the CDRH.

Regulatory Pathways

The CDRH offers several regulatory pathways for medical devices, including:

• 510(k) Premarket Notification: A process for demonstrating that a new device is substantially equivalent to a legally marketed device.

• Premarket Approval (PMA): A more rigorous process required for high-risk devices, involving a thorough review of clinical data.

• De Novo Classification: A pathway for novel devices that are low to moderate risk but do not have a predicate device.

Challenges and Initiatives

The CDRH faces challenges such as keeping pace with rapid technological advancements and ensuring the safety of increasingly complex devices. To address these challenges, the CDRH has launched initiatives to improve the regulatory process, enhance postmarket surveillance, and foster innovation.

Related pages

• United States Food and Drug Administration
• Medical device
• Radiation protection
• Public health