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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).

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By ReguVirta
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  1. Review current product labeling to assess feasibility of adding URL
  2. If feasible, update product labels to include company URL
  3. Ensure website contains required manufacturer information or clear link to it
  4. Implement process to update website address information within 15 days of any change
  5. Maintain compliance with existing identification tag/label requirements
  6. Review website content considering it may be interpreted as product labeling
  7. 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

  • 21 CFR 1010.3: Performance standards for electronic products: general

Original guidance

  • Including Manufacturer’s URL on Electronic Product Labels
  • HTML / PDF
  • Issue date: 2010-09-29
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Labeling, Postmarket
  • ReguVirta summary file ID: fb41de88cda876a59e1ec8fa60f68bbb
FDA guidance, Final
Medical Devices Labeling Postmarket
This post is licensed under CC BY 4.0 by the author.