Guidance for Industry and FDA Staff 
 
Acceptable Media for Electronic 
Product User Manuals 
 
 
 
 
Document issued on: March 18, 2010  
 
For questions regarding this document, contact Bob 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 
 
Electronic Products Branch 
Division of Mammography, Quality, and Radiation Programs 
Office of Communication, Education, and Radiation Programs 
 
  Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
Written comments and suggestions may be submitted 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.  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/ucm20
5782.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 301-847-8149 to receive a hard copy.  Please use the 
document number (#1710) to identify the guidance you are requesting. 
 
 
  
 
  Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA Staff 
 
Acceptable Media for Electronic 
Product User Manuals  
 
This guidance represents the Food and Drug Administrations (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 has developed this guidance document to allow manufacturers to provide user manuals 
accompanying electronic products in either paper or electronic form.  This is done to recognize 
that electronic media are now being widely used to provide instruction, while at the same time 
reducing paper consumption, increasing accessibility and providing rapid means for editing and 
updating content. 
 
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. User Manuals 
The Code of Federal Regulations (CFR) Title 21 Part 1002.3 states in part: The Director... of the 
Center for Devices and Radiological Health... may require a manufacturer of a radiation emitting 
electronic product to provide to the ultimate purchaser...performance data and other technical 
data related to safety of the product...  These data are typically contained in user manuals that 
accompany electronic products and historically the media for these manuals has been printed 
paper.  Specific performance standards in 21 CFR Parts 1020.20(c)(4)(i), 1020.30 (h), 1020.40 
(c)(9), 1030.10(c)(4), 1040.10(h), 1040.20(e), and 1050.10(f)(2) also contain requirements for 
providing instructions to users of electronic products.  For example, 21 CFR 1020.30(h) and 
  Contains Nonbinding Recommendations 
 
1040.10(h) specify information manufacturers must provide to users of diagnostic x-ray and laser 
products respectively. 
With the availability of electronic information storage and display technology, many commercial 
product manuals are being provided electronically.  Electronic documentation saves storage 
space, reduces paper consumption, increases accessibility, and provides rapid means for editing 
and updating of content. 
For these reasons, the Center for Devices and Radiological Health (CDRH) will 
allow manufacturers to provide the required user information in a commonly used electronic 
format (e.g. Adobe Acrobat or Rich Text Format).  Manufacturers may provide the required 
information as a web site download, on a compact disc (CD) or on other storage media in 
common use (e.g. USB external drive), so long as it is made available directly to the purchaser of 
the product.  If the product purchaser is unable to access the electronic version provided, the 
manufacturer must make the required documentation available in hard copy (e. g. printed paper) 
at no additional cost. The manuals in whatever form provided should be in the English language. 
3.  Impact on Required Reports 
Radiation safety reports (including user manuals) required by 21 CFR 1002.10 through 1002.13 
may be submitted to FDA in one of the following ways: 
1) Electronically using FDAs eSubmitter software which can be downloaded at no cost from 
http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm. Documents prepared using 
eSubmitter may be sent directly to CDRH via FDAs Electronic Submissions Gateway (ESG). 
2) On CD using FDAs eSubmitter software.  Documents prepared using eSubmitter may be 
loaded on a CD and mailed to CDRH for processing, or 
3) In hard copy, paper documentation may be mailed to the address shown at 
http://www.fda.gov/Radiation-
EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/RecordsandReport
ing/ucm118122.htm. 
Note: FDA will not accept electronic versions of user manuals unless the required radiation safety 
report is also submitted electronically. 
 
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