Private Label Medical Device Definition

Device Labeling | FDA - U.S. Food and …

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

Device Labeling | FDA Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops and administers regulations under...

FAQs about the New Device Registration and Listing …

https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements

Private Labeled Devices with FDA Approval

https://medicaldeviceacademy.com/private-labeled-devices-with-fda-approval/

Answer to the third question about private labeled devices. There is no formal process for “getting a private label.” The entire private label process is …

Guidance Document - Private Label Medical Devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-private-label-medical-devices.html

"private label manufacturer" means a person who sells a private label medical device under their own name or trademark. "private label medical device" means a …