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
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.
Send and Track Medical Device Premarket Submissions Online
2024年11月15日 · The U.S. Food and Drug Administration (FDA) updated CDRH’s Customer Collaboration Portal (CDRH Portal) to: Accept Small Business Determination (SBD) requests.
Establishment Registration & Device Listing - Food and Drug Administration
2025年3月17日 · 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).
CDRH Advisory Meeting Materials Archive - Food and Drug Administration
CDRH Advisory Meeting Materials Archive. FDA Home; Advisory Committees; Committees & Meeting Materials; Medical Devices - Search Advisory Panel/Committee Meetings: ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press;
Recognized Consensus Standards: Medical Devices - Food and Drug …
2024年12月23日 · This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity for medical devices.
Layoffs hit FDA’s Center for Devices and Radiological Health - STAT
2025年2月16日 · Layoffs at the FDA appear to have hit the AI and digital health staff particularly hard. It also has a strained relationship with Musk’s company Neuralink.
CDRH Learn | FDA - U.S. Food and Drug Administration
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 ...
FDA keeps an expansive list of activities that require an innovator to register, list, and pay fees. Below is a subset of the activities that NIH innovators are most involved in and their registration requirements.