Cdrh Medical Device

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability Science and Research CDRH research programs, epidemiology,...

Center for Devices and Radiological Health | FDA

https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health

In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and …

Medical Device Databases | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Apr 6, 2022

CDRH Learn | FDA - U.S. Food and Drug Administration

https://www.fda.gov/training-and-continuing-education/cdrh-learn

Welcome to CDRH Learn, the FDA Center for Devices and Radiological Health's (CDRH) web page for multimedia industry education. CDRH Learn is our innovative educational …

Establishment Registration & Device Listing - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

CDRHNew - News and Updates | FDA

https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates

Federal Register: Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal …

Overview of Medical Device Classification and …

https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of …

CDRH 2022 Annual Report | FDA

https://www.fda.gov/about-fda/cdrh-reports/cdrh-2022-annual-report

The FDA’s Center for Devices and Radiological Health (CDRH) released its 2022 Annual Report to highlight the Center’s programmatic accomplishments through …

Guidance Documents (Medical Devices and Radiation …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. …

Medical Device Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a …