Guidance for Industry
Labeling for Electronic
 Anti-Theft Systems
Document issued on: August 15, 2000
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Electronic Product Devices Branch
Division of Enforcement III
Office of Compliance Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to,
Food and Drug Administration, Center for Devices and Radiological Health, Office of
Compliance, Division of Enforcement III, 2094 Gaither Road, Rockville, Maryland 20860.
Comments may not be acted upon by the Agency until the document is next revised or
updated.  For questions regarding the use or interpretation of this guidance contact
Lieutenant Sean Boyd at (301) 594-4654, ext. 128 or by electronic mail at
SBB@cdrh.fda.gov.
Additional Copies
World Wide Web/CDRH home page:  http://www.fda.gov/cdrh/comp/guidance/1170.pdf,
or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 1170
when prompted for the document shelf number. 1
Guidance on Labeling for Electronic
 
Anti-Theft Systems
August 15, 2000
Dear Electronic Anti-Theft System Manufacturer,
The purpose of this letter is to recommend that all manufacturers of electronic anti-theft systems
develop labeling or signage to post on or near all new and currently installed systems, indicating that
an electronic anti-theft system is in use.  Such labeling or signage will permit implant wearers to
avoid lingering around or leaning against systems that may affect their implanted electronic medical
devices.
Interference concerns
Implantable electronic medical devices may be affected by the electromagnetic radiation produced
by electronic anti-theft systems.  The Food and Drug Administration (FDA) received 63 reports
over the past 10 years describing electromagnetic interference (EMI) to implantable devices caused
by various types of anti-theft systems.  Of the 63 reported incidents, 49 were caused either by anti-
theft systems, electronic article surveillance (EAS) systems, or security systems.  The affected
devices in these reports included pacemakers, neurological stimulators, and implantable cardioverter
defibrillators.  Examples of the reported effects on the device included changes in the rate of
stimulation (e.g., increase of pacing rate), changes in the level of stimulation (e.g., neurological over
or under stimulation), and changes in the mode of stimulation (e.g., reprogramming).  Examples of
reported effects on the implant wearer range from unconsciousness and sensation of pain, to
wearers being unaware that an interaction occurred.  These effects on the implant and the wearer
are typically transient and unlikely to cause clinically significant symptoms in most wearers.
Collaborative efforts
At the 1998 and 1999 meetings of the Technical Electronic Products Radiation Safety Standards
Committee (TEPRSSC), local and federal government agencies, the anti-theft industry, and the
medical community came together to address this issue in a public forum.  The TEPRSSC urged
each of the stakeholders in this issue to work together, research the
                                                                
1 This document is intended to provide guidance.  It represents the Agency's current thinking on the above.  It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  An
alternative approach may be used if such approach satisfies the requirements of the applicable statute,
regulations, or both. problem, and identify solutions to reduce the risk of EMI to implantable electronic medical devices.
The FDA sent a letter in 1998 containing important information for doctors and patients on the issue
of anti-theft system interference with implantable devices.  That letter affirmed recommendations
made by the anti-theft system industry and medical community that implant wearers should practice
dont linger, dont lean around electronic anti-theft systems.  The FDA applauds the collaborative
efforts put forth by the anti-theft industry and the medical community over the past two years to
mitigate  anti-theft  system  interference  with  implantable  devices.    More  importantly,  the  FDA
encourages your continued cooperation toward this effort.
Recommendations
The FDA recognizes that the likelihood of anti-theft systems interfering with implantable electronic
medical devices is low.  The number of adverse event reports indicates that a relatively small
number of individuals have been affected within a large population of implant wearers.  Further, the
reports describe a majority of the interactions as moderate or mild in nature, with little or no
significant effect on the implant wearers.
In light of advances in implantable electronic device technology and increasing numbers of implant
wearers,  the  FDA  believes  that  implant  wearers  should  be  notified  whenever  and  wherever
electronic anti-theft systems are in use.  The FDA recommends that anti-theft system manufacturers
develop either labeling or signage that can be posted on or near new and installed anti-theft
equipment to further reduce the risk of interference.
Examples of appropriate language for such labeling and signage may include:  ELECTRONIC
ANTI-THEFT SYSTEM IN USE or ELECTRONIC SECURITY SYSTEM IN USE.
Anti-theft systems employing visible monitoring elements (e.g., towers) may simply have a label
affixed to the surface of the element.  Signage may be posted for systems employing either visible or
concealed (e.g., installed in the walls or ceiling) monitoring elements.  In either case, the FDA
recommends that labeling or signage be positioned so that it is visible before an individual enters the
monitored  area.    FDA  also  recommends  that  you  include  labeling  and  signage  with  all  new
equipment in addition to the signage provided to facilities wherever anti-theft systems are currently
installed.
It  is  important  that  manufacturers  of  anti-theft  systems,  the  retail  industry,  and  the  medical
community continue to develop mutually agreeable solutions to this issue.  The use of labeling or
signage on electronic anti-theft systems will enable implant wearers to take appropriate precautions
to further minimize the risk of interference, namely to avoid lingering around or leaning on such systems.  The labeling or signage may also provide an additional
deterrent against theft while relaying this important information.
If you have any questions regarding this letter, please contact Sean Boyd, CDRH, Office of
Compliance (HFZ-342), 2094 Gaither Rd., Rockville, MD  20850,  sbb@cdrh.fda.gov (email),
301-594-4672 (fax).
Sincerely yours,
Steven M. Niedelman
Acting Director
Office of Compliance
Center for Devices and
     Radiological Health
Cc:  Implantable device manufacturers
Implantable device physicians
Retail industry groups