Center for Devices and Radiological Health | FDA
2024年1月24日 · In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health by assuring that patients and providers have...
CDRH Offices | FDA - U.S. Food and Drug Administration
2023年1月5日 · FDA's Center for Devices and Radiological Health has eight offices that cover the total product lifecycle of regulated medical devices and radiation-emitting products.
CDRH Learn | FDA - U.S. Food and Drug Administration
2024年12月3日 · CDRH Learn is our multi-media educational resource, featuring learning modules that address medical device and radiation emitting product laws, regulations, guidances, and policies, across the ...
Establishment Registration & Device Listing - Food and Drug Administration
5 天之前 · Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA....
FDA Center for Devices and Radiological Health - Wikipedia
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).
Premarket Approval (PMA) - Food and Drug Administration
2024年12月2日 · Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Product Classification - Food and Drug Administration
5 天之前 · a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. Learn More...
FDA CDRH Summer 2025 Research Participation Program
FDA Office and Location: Summer research opportunities are available at the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) located in Silver Spring, Maryland.
It's official: Michelle Tarver named director of the FDA's devices …
2024年10月22日 · Last week, the outgoing leader of the FDA’s devices center, longtime chief Jeff Shuren, M.D., endorsed acting head Michelle Tarver, M.D., Ph.D., on a stage in front of the medtech industry ...
Michelle Tarver faces challenges as new CDRH leader. But patient …
2024年10月31日 · Tarver was named permanent director last week after spending more than 15 years with CDRH. Some of her accomplishments include helping build the first patient engagement advisory committee at the FDA, developing patient-reported outcome measures, and conducting trials and surveys to capture patient preferences.