Designation Of Medical Devices

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three...

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 …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Overview of Device Regulation | FDA

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

Medical Device Listing - 21CFR Part 807 Manufacturers must list their devices with the FDA. Establishments required to list their devices include: …

Breakthrough Devices Program | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

The FDA recommends that your designation request include information to describe the device, the proposed indication for use, regulatory history, how your device …

2022 Device Approvals | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/recently-approved-devices/2022-device-approvals

Medical Devices; Products and Medical Procedures; Device Approvals, Denials and Clearances; ...

Remanufacturing and Servicing Medical Devices | FDA

https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/remanufacturing-and-servicing-medical-devices

The availability of timely, cost-effective, quality maintenance and repair of medical devices is critical both to the successful functioning of the United States (U.S.) …

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

Medical devices are used in many diverse settings, for example, by laypersons at home, by paramedical staff and clinicians in remote clinics, by opticians …

Medical Device Classification (FDA & EU MDR)

https://www.simplerqms.com/medical-device-classification/

The EU MDR has 4 categories of devices: Non-invasive medical devices Invasive medical devices Active medical devices Special category The medical …