The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Examples of products that CDRH regulates include medical devices ranging from tongue depressors and personal protective equipment (PPE) to pacemakers and robotic surgical systems, and medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions. As of October 2024, the Director of CDRH is Michelle Tarver M.D., Ph.D.

Organization structure

CDRH consists of seven offices that work in collaboration to assure that consumers have access to safe and effective medical products.

Office of Product Evaluation and Quality

The Office of Product Evaluation and Quality (OPEQ), one of the seven offices in CDRH, is structured to monitor the entirety of a medical product's evolution. Pre-market and post-market teams work together to evaluate the safety and effectiveness of medical devices. OPEQ houses the Office of Health Technologies (OHT), which is further subdivided into 8 offices by device type. Each office performs reviews of products over their lifecycle.

History

Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. In the 1970s, Congress responded to the public's desire for additional oversight over medical devices by passing the [https://en.wikipedia.org/wiki/Medical_Device_Regulation_Act#:~:text=The%20Title%2021%20amendments%20were,Ford.&text=An%20Act%20to%20amend%20the,use%2C%20and%20for%20other%20purposes. Medical Device Amendments of 1976 (MDA)] to the FD&C. The MDA established a risk-based framework for the classification of medical devices and a regulatory pathway for medical devices to get to the market, created a regulatory pathway for medical device clinical trials, and established several post-market requirements including manufacturer registration and device listing with the FDA, good manufacturing practices (GMPs), and reporting of adverse events. Another predecessor of CDRH was the Public Health Service's Division of Radiological Health, which was formed in the late 1950s within the Environmental Health Divisions of the Bureau of State Services. In 1970, as part of the Public Health Service reorganizations of 1966–1973, this division was split, with part going to the new Environmental Protection Agency and part moving into FDA. In 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH). Former leaders of CDRH

Medical Device Legislation Milestones

CDRH mission and vision

The CDRH vision is that patients in the U.S. have access to high-quality, safe, and effective medical devices. CDRH works diligently to advance and interweave innovation and safety priorities to fulfill the mission of protecting and promoting public health.

Strategic priorities

In order to maintain and continuously improve the vision for high-quality safe and effective medical devices for all patients, CDRH regularly develops strategic priorities. The following were established for 2022 – 2025. Promote a Modern and Diverse Workforce: CDRH strives to prepare the organization so it is exceedingly proactive, flexible, resilient, collaborative, and engaged. Enhance Organizational Agility and Resilience: CDRH makes efforts to adapt and redesign business processes, approaches, and policies to anticipate the needs of the future. Advance Health Equity: CDRH aims to advance the development of knowledge and safe and effective technologies to meet the needs of all patients and consumers.

CDRH initiatives

Continuing partnerships with patients

Initiatives to encourage innovation and collaboration with innovators

Initiatives to encourage safety and quality

Initiatives to enhance regulatory flexibility