FDA and Health Canada joint regulation submission pilot uses GMDN


The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch the joint eSTAR pilot. Requests for participating in the pilot are now open.

The pilot will test the use of a single regulatory submission to both the FDA and Health Canada.

The submission will need to include the GMDN Term for the product and therefore will be useful for demonstrating how the GMDN supports international harmonisation using an accurate generic name for the device type. Requests for participating in the pilot are now open.

More information is available from the FDA and Health Canada.

Health Canada
www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/notice-industry-health-canada-fda-estar-pilot/estar-pilot-program.html

US FDA
www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot