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.
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 ...
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.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
2024年12月24日 · CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CLIA; Device Classification; FDA Guidance Documents ; ... 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;
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).
Medical Device Recalls - Food and Drug Administration
5 天之前 · This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the...
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.
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.
FDA Center for Devices and Radiological Health (CDRH) - NCI
The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic (FD&C) Act.
- 某些结果已被删除