Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA 
Staff  
Approval of Alternate Means of 
Labeling for Laser Products 
(Laser Notice 53) 
 
Document issued on March 23, 2007  
 
 
For questions regarding this document contact Jerome E. Dennis, 240-276-3330, 
jerome.dennis@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 
  1 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/radhealth/products/lasers.html.  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 
240-276-3151 to receive a hard copy.  Please use the document number (1633) to identify the 
guidance you are requesting. 
  2 Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff  
 
Approval of Alternate Means of Labeling 
for Laser Products 
(Laser Notice 53)  
 
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.  
 
Introduction 
Under current radiological health regulations, the Center for Devices and Radiological 
Health (CDRH) may approve alternate means for manufacturers of laser products to provide 
required certification, identification, and warning labeling in cases where it is not feasible to 
provide the labeling as specified in the regulations (21 CFR 1010.2, 1010.3, 1040.10(g)).  
CDRH may approve alternate means of providing the certification and identification upon 
the manufacturers application (21 CFR 1010.2(d), 1010.3(b)). CDRH on its own initiative or 
in response to a manufacturers written application may approve either alternate means of 
providing the labels or alternate wording for the warning labeling required under 1040.10(g).  
 
CDRH is issuing this guidance to inform manufacturers that the FDA intends to exercise 
enforcement discretion, under certain circumstances described later, as to its current 
regulations governing the provision of certification, identification, and warning labeling for 
laser products and obtaining approval of alternate means of providing this information.  
 
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. 
 
  3 Contains Nonbinding Recommendations 
 
 
The Least Burdensome Approach 
We believe we should consider the least burdensome approach in all areas of medical device 
and electronic product regulation.  This guidance reflects our careful review of the relevant 
scientific and legal requirements and what we believe is the least burdensome way for you to 
comply with those requirements.  However, if you believe that an alternative approach would 
be less burdensome, please contact us so we can consider your point of view.  You may send 
your written comments to the contact person listed in the preface to this guidance or to the 
CDRH Ombudsman.  Comprehensive information on CDRH's Ombudsman, including ways 
to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.  
 
1.  Issue 
The applicable regulations in 21 CFR 1010.2, 1010.3, and 1040.10(g) require that 
manufacturers provide certification, identification, and warning labeling in a specified 
manner. However, the regulations contain provisions for CDRH to approve alternate means 
of providing the required labeling in cases where it is not feasible to provide the labeling as 
specified in the regulation, often due to size.  Alternate means may be approved by CDRH 
upon application by the manufacturer (21 CFR 1010.2, 1010.3, and 1040.10(g)). However, 
due to the increasing numbers of laser products of small size and the overall increase in the 
number of manufacturers and minimal risk to public health, CDRH intends to exercise 
enforcement discretion, under certain circumstances, and permit manufacturers of laser 
products to use alternate means of providing the required information without applying to 
and receiving approval from CDRH.  
 
2.  Guidance 
Under what circumstances may manufacturers use alternate means of providing the 
required certification, identification, or warning labeling, without applying to and 
receiving approval from CDRH? 
 
Alternate means of labeling may be used without applying to and receiving approval 
from CDRH when  
  size 
  configuration 
  design 
  function 
  sterilization 
or other considerations make the placement of the labels as required by the 
regulations and performance standard impractical. 
 
 
 
 
What are some examples of alternate means of providing required labeling? 
  4 Contains Nonbinding Recommendations 
 
 
Examples of alternate means of providing required labeling include 
  Placement of labels on packaging 
  Placement of labels in user instructions 
  Placement of labels on alternate portions of the product 
 
What should manufacturers do if using alternate means without applying to and 
receiving approval from CDRH? 
 
As is currently the case, manufacturers who use alternate meanswhether they applied for 
and received approval for the alternate means from CDRH or based on this guidance--should 
document this in the product report and retain in-house the justification for use of alternate 
means for review upon CDRH request. 
 
If, in its review of a manufacturers product report, CDRH believes a particular laser product 
should have been labeled in accordance with the regulations, CDRH may notify the 
manufacturer and require recall of the product for relabeling or a change in the labeling in 
future production in accordance with 21 CFR 1003 and 1004.   
 
Manufacturers also may contact CDRH to discussion whether this guidance applies to their 
product. Please note, however, that CDRH does not act as an intermediary between 
manufacturers and testing laboratories from which the manufacturer may have sought 
independent certification of conformance.  
 
3.  Getting More Information 
You can get more information about our requirements for lasers from our electronic product 
radiation control web page http://www.fda.gov/cdrh/radhealth/. 
 
If you have any questions about this guidance, contact Jerome Dennis, Center for Devices 
and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Drive, 
Rockville, Maryland 20850 or jerome.dennis@fda.hhs.gov. 
 
 
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