Guidance for Industry and  
Food and Drug Administration Staff 
 
Addition of URLs to Electronic 
Product Labeling 
 
 
 
Document issued on:  September 30, 2010  
 
For questions regarding this document contact Robert Doyle at 301-796-5863 or via email at 
robertj.doyle@fda.hhs.gov . 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of Communications, Education, and Radiation Programs 
Division of Mammography Quality and Radiation Programs 
Electronic Products Branch 
 
  Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
You may submit written comments and suggestions at any time for Agency consideration to the 
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD, 20852.  Submit electronic comments to www.regulations.gov.  When 
submitting comments, please refer to the exact title of this guidance document.  Comments may not 
be acted upon by the Agency until the document is next revised or updated.   
 
Additional Copies 
Additional copies are available from the Internet at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm22
8553.htm  You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic 
copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy.  Please use the 
document number (1703) to identify the guidance you are requesting 
 
  
 
  2 Contains Nonbinding Recommendations 
 
Guidance for Industry and  
Food and Drug Administration Staff 
 
Addition of URLs to Electronic Product 
Labeling 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance.  
 
 
1.  Introduction 
FDA is issuing this guidance document to recommend 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.  FDAs 
decision to encourage the addition of URLs on electronic products is a result of the recognition 
that URLs are now widely used in product identification.  In addition, using a manufacturers 
website address enables the manufacturer to provide the manufacturers location and details that 
would not typically be included in a product tag or label, and allows the manufacturer to promptly 
update its address information whenever there is a change.   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
2. Identification Labels 
Manufacturers of electronic products are required to include their full name and address and 
place, month and year of manufacture on their products identification tag or label (21 CFR 
1010.3(a)(1) and (2)).  CDRH recommends that, when feasible, the manufacturer add its URL to 
  3 Contains Nonbinding Recommendations 
 
its electronic product tag or label, in addition to the identification information required under 21 
CFR 1010.3(a)(1) and (2).  CDRH does not, however, recommend inclusion of the URL in 
instances where a manufacturer is unable to place its URL, in addition to the required full name 
and address and place, month and year of manufacture, on its current product label in a manner 
that is legible and readily accessible to view when the product is fully assembled for use or in 
such other manner as may be prescribed in the applicable performance standard.   
When a manufacturer adds its URL to a product tag or label, the URL should point directly to: 
1.  A web page where the manufacturers full name and current physical address are 
posted, or 
 
2.  A web page which displays an easily identifiable link (e.g. Contact Us) that 
connects to a web page where the manufacturers full name and current physical 
address are posted. 
 
In addition, the manufacturers physical address should be kept current on the manufacturers 
website by updating any change to its physical address no later than 15 days following a change. 
 
Under certain circumstances, FDA may determine that information about an electronic product on 
a firm's website is "labeling" within the meaning of section 201(m) of the Federal Food, Drug, 
and Cosmetic Act.  The presence of the URL on the product label is one factor the Agency may 
consider in making such a determination. 
  4