Including Manufacturer's URL on Electronic Product Labels
This guidance recommends manufacturers to include their Uniform Resource Locator (URL) on electronic product labels in addition to the mandatory requirements for identification tags/labels under 21 CFR 1010.3(a)(1) and (2).
What You Need to Know? 👇
What are the requirements for electronic product identification labels under FDA regulations?
Manufacturers must include their full name and address, plus the place, month, and year of manufacture on electronic product identification tags or labels per 21 CFR 1010.3(a)(1) and (2).
Is adding a URL to electronic product labeling mandatory under FDA guidance?
No, adding a URL is recommended but not required. The FDA guidance suggests including URLs when feasible, but it’s not a legal requirement under current regulations.
Where should the manufacturer’s URL link when added to product labels?
The URL should link directly to a webpage showing the manufacturer’s full name and current physical address, or to a page with an easily identifiable link (like “Contact Us”) leading to that information.
How quickly must manufacturers update address information on their websites?
Manufacturers must update any changes to their physical address on their website no later than 15 days following the change to maintain current contact information.
When should manufacturers avoid adding URLs to their electronic product labels?
URLs shouldn’t be added if they cannot be placed legibly and accessibly alongside required identification information when the product is fully assembled for use, or as prescribed in applicable performance standards.
Can website information be considered “labeling” under FDA regulations?
Yes, under certain circumstances, FDA may determine that information about an electronic product on a firm’s website constitutes “labeling” under section 201(m) of the Federal Food, Drug, and Cosmetic Act.
What You Need to Do 👇
Recommended Actions
- Review current product labeling to assess feasibility of adding URL
- If feasible, update product labels to include company URL
- Ensure website contains required manufacturer information or clear link to it
- Implement process to update website address information within 15 days of any change
- Maintain compliance with existing identification tag/label requirements
- Review website content considering it may be interpreted as product labeling
- Document decision-making process regarding URL inclusion or exclusion based on label space constraints
Key Considerations
Labelling
- Manufacturer’s full name and address must be included on product identification tag/label
- Place, month, and year of manufacture must be included on product identification tag/label
- URL should be added when feasible
- URL should point directly to:
- A web page with manufacturer’s full name and current physical address, or
- A web page with an easily identifiable link to contact information
- Physical address on website should be updated within 15 days following any change
- Label information must be legible and readily accessible when product is fully assembled
Other considerations
- Website information may be considered “labeling” under section 201(m) of the Federal Food, Drug, and Cosmetic Act
- URL inclusion is not recommended if it compromises the legibility of required information on the current product label
Relevant Guidances 🔗
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms 📂
- 21 CFR 1010.3: Performance standards for electronic products: general