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...
Send and Track Medical Device Premarket Submissions Online
2024年10月3日 · The U.S. Food and Drug Administration (FDA) updated CDRH’s Customer Collaboration Portal (CDRH Portal) to: Accept Small Business Determination (SBD) requests.
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.
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).
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
2024年8月30日 · § 312.40 - General requirements for use of an investigational new drug in a clinical investigation. § 312.41 - Comment and advice on an IND. § 312.42 - Clinical holds and requests for...
510(k) Premarket Notification - Food and Drug Administration
4 天之前 · A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section...
Premarket Approval (PMA) - Food and Drug Administration
2024年11月18日 · Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
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 ...
Chemicals List for Analytical Performance (CLAP)
This catalog collates a variety of regulatory science tools that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) developed and...
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.