For those currently or intending to distribute electronic labeling for their medical devices, be aware that in 2010 FDA issued a guidance entitled “Addition of URL to Electronic Product Labeling”. This guidance contains a recommendation:
“ …that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under 21 CFR 1010.3(a)(1) and (2) that manufacturers include their full name and address and place, month and year of manufacture on their electronic product identification tags or labels…”
It also states that changes in physical address should be updated within 15 days of the change.
The full guidance is at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm228553.htm
