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 · All CDRH-led premarket submission types may be uploaded to the CDRH Portal at any stage of the review process.
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.
510(k) Premarket Notification - Food and Drug Administration
2024年11月18日 · 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...
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).
FDA sets new record for novel device green lights in CDRH annual …
2024年1月22日 · In what the FDA described as a “transformative year” for its Center for Devices and Radiological Health, the agency set a new record in issuing green lights to innovative medical devices and ...
Recognized Consensus Standards: Medical Devices - Food and Drug …
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8月30日 · Subpart A - General Provisions § 312.1 - Scope. § 312.2 - Applicability. § 312.3 - Definitions and interpretations. § 312.6 - Labeling of an investigational new drug. § 312.7 - Promotion of investigational drugs. § 312.8 - Charging for investigational drugs under an IND. § 312.10 - Waivers.. Subpart B - Investigational New Drug Application (IND)
CDRH Learn | FDA - U.S. Food and Drug Administration
CDRH Webinars. CDRH Webinars feature FDA presentations and live stakeholder question and answer discussions about timely medical device laws, regulations, guidances, or programs.
Regulatory Science Tools Catalog | Center for Devices and …
These tools do not replace FDA-recognized standards or MDDTs. 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.
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