Guidance for Industry and FDA 
Staff 
 
Exemption from Reporting and 
Recordkeeping Requirements for 
Low Power Laser Products  
 
(Laser Notice 54) 
 
 
 
Document Issued on: January 6, 2006 
 
 
For questions regarding this document contact Jerome E Dennis, 301-796-5710, 
jerome.dennis@fda.hhs.gov.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Electronic Product Devices Branch 
Division of Mammography Quality 
Assurance 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/cdrh/radhlth, you may
also sent an email 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 document number
(1592) to identify the guidance you are requesting.
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff  
Exemption from Reporting and 
Recordkeeping Requirements for Low Power 
Laser Products 
(Laser Notice 54) 
  
 
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 21 CFR 1002.50, FDA may exempt manufacturers of electronic products from reporting 
and record requirements subject to any conditions necessary to protect the public health and 
safety. This guidance provides notification of FDAs exemption of specified low power laser 
products from certain reporting requirements because of the low risk of exposure to laser 
radiation and minimal risk to health posed by the products identified in this guidance. 
 
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. 
 
  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/. 
 
Issue 
All manufacturers of electronic products, which includes all laser products, must submit product 
and supplemental reports according to Title 21 of the Code of Federal Regulations (21 CFR) 
Parts 1002.10 and 1002.11.  In 1988, FDA exempted manufacturers of certain low power laser 
products from some reporting and recordkeeping requirements if the exempted models met 
specified criteria (http://www.fda.gov/cdrh/radhlth/pdf/laser-notice-41.pdf).  FDA is now superseding that 
guidance and expanding that exemption to additional laser products that do not pose a risk to the 
public based on their design or use. 
 
Guidance 
What products does the exemption include? 
 
  Class I optical disc products, such as CD or DVD players, readers, or recorders, whether 
the products are stand-alone units, installed into other systems (such as computers or 
automobiles), or intended to be installed into other systems, and 
  Class I laser products intended for home or office use, such as laser printers, that totally 
enclose any laser radiation that they generate, and in addition 
  Any laser products that do not by virtue of their design allow human access to laser 
radiation in excess of the accessible emission limits of Class I specified in 21 CFR 
1040.10(d), as determined in accordance with 21 CFR 1040.10(e), under any condition 
of operation, maintenance, service, or failure.  
 
What are the conditions for use of the exemption? 
 
  The manufacturer must test and certify that the exempted class I laser products comply 
with the Federal performance standard contained in 21 CFR 1040.10 and 1040.11. 
  The manufacturer must have submitted at least one product report on any similar or 
different type of laser product. 
 
  Contains Nonbinding Recommendations 
 
What requirements are reduced by this exemption? 
 
Manufacturers of the class I laser products described above are exempted from: 
 
  Certain product reports required by 21 CFR 1002.10 
  All supplemental reports required by 21 CFR 1002.11  
  Certain recordkeeping requirements described in 21 CFR 1002.30(b), 1002.40 and 
1002.41 
 
provided the conditions for use described above are met. 
 
What requirements are not included in this exemption? 
 
1.  Annual reports: 
 
The manufacturer must continue to submit annual reports required by 21 CFR 1002.13, 
which contain listings of all products tested and certified during the reporting year.  The 
listing must include all laser products that were distributed into U.S. commerce during the 
reporting period, both those that are and those that are not exempt from submission of 
product reports and supplements.  
 
2.  Manufacturers must continue to meet all other applicable requirements, including: 
 
  21 CFR 1002.20 (Reporting of Accidental Radiation Occurrences)  
  21 CFR 1002.30(a) and 1002.31 (Manufacturer's Records)  
  21 CFR 1003 (Notification of Defects or Failure to Comply)  
  21 CFR 1004 (Repurchase, Repairs, or Replacement of Electronic Products). 
 
Can the Center revoke this exemption? 
 
Yes.  FDA reserves the right to request information concerning these products or full reports and 
recordkeeping if it determines this to be necessary in keeping with the intent of the Radiation 
Control for Health and Safety Act of 1968 (Public Law 90-602).  This would be the case if FDA 
has reason to believe that a manufacturer is not abiding by the conditions of the exemption. 
 
Why is FDA granting this exemption? 
 
This exemption reduces the regulatory burden on manufacturers of laser products meeting these 
criteria.   
 
  Contains Nonbinding Recommendations 
 
Getting More Information 
You can get more information about our requirements for lasers from our electronic product 
radiation control web page at http://www.fda.gov/cdrh/radhlth/. 
If you have questions about this guidance, contact Jerome Dennis, CDRH Office of 
Communication, Education, and Radiation Programs, 9200 Corporate Boulevard, Rockville, MD 
20850 or jerome.dennis@fda.hhs.gov.