Regulating Medical Devices

Overview of Device Regulation | FDA

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

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device Listing, Premarket...

FDA's Role in Regulating Medical Devices | FDA

https://www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-medical-devices

In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must …

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. …

An Introduction to FDA’s Regulation of Medical Devices

https://www.fda.gov/media/123602/download

Verify that Productis Medical Device Identify Classification and Regulatory Pathway Identify regulatory classification Classification will generally indicate regulatory pathway …

General Controls for Medical Devices | FDA

https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the FDA. They can be found in 16 medical specialties or device …

Remanufacturing and Servicing Medical Devices | FDA

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

The FDA enforces requirements under the FD&C Act and its implementing regulations on entities engaged in remanufacturing, including but not limited to …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

A History of Medical Device Regulation and Oversight in …

https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states

A History of Medical Device Regulation & Oversight in the United States The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency in …

Regulatory 101: Medical Devices | Design of Medical …

https://dmd.umn.edu/reg-101

This full day workshop will provide insights into the basics of the medical device regulation to help you understand activities needed to bring a medical device to market and to …