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Device Labeling | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
- Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws...
Electronic Labeling: A US Perspective - DIA Global Forum
- https://globalforum.diaglobal.org/issue/july-2020/global-electronic-labeling-initiatives-updates-from-japan-canada-europe-us-and-asia/
- In the guidance, eLabeling refers to product information, including the package insert (PI) and patient information leaflet (PIL), which is …
E-labelling: Tips for the medical device industry
- https://www.med-technews.com/medtech-insights/e-labelling-tips-for-the-medical-device-industry/
- As a part of the EU’s new Medical Device regulations, any device manufacturer with a website will need to publish user information …
General Device Labeling Requirements | FDA
- https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements
- The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. Later sections in …
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