*Pages 1--8 from  Microsoft Word - 54364.doc*
 Federal  Communications  Commission  FCC  06-  1 
 Before  the  Federal  Communications  Commission 
 Washington,  D.  C.  20554 

 In  the  Matter  of 
 DexCom,  Inc  . 
 Request  for  Waiver  of  the  Frequency  Monitoring  Requirements  for  the  Medical  Implant 
 Communications  Service  Rules 

 )  ) 
 )  ) 
 )  ) 
 )  ) 
 ET  Docket  No.  05-  213 

 ORDER 
 Adopted:  January  12,  2006  Released:  January  18,  2006 
 By  the  Commission: 

 I.  INTRODUCTION 
 1.  By  this  Order,  we  grant  a  request  for  waiver  filed  by  DexCom,  Inc.,  1  authorizing  it  to  build  and  market  its  blood  glucose  monitoring  system  to  operate  in  the  Medical  Implant  Communications 

 Service  (MICS)  band.  2  This  waiver  is  granted  for  a  period  of  three  years,  or  until  such  time  as  the  Commission  amends  its  rules  related  to  such  devices  to  obviate  the  need  for  a  waiver  or  to  specify  rules 
 with  which  devices  of  this  kind  will  be  required  to  comply. 
 2.  The  DexCom  STS  (short-  term)  and  LTS  (long-  term)  blood  glucose  monitoring  sensors  are  devices  implanted  into  the  body  that  combine  a  monitor  with  a  low-  power  transmitter  to  provide 

 frequent,  periodic  information  regarding  blood  glucose  levels.  These  monitor  readings  are  transmitted  to  a  receiver  worn  by  a  diabetic  patient,  so  that  the  patient  can  continuously  monitor  his/  her  blood  glucose 
 level  and  take  nutrition  or  medication  (insulin)  as  necessary  to  maintain  an  appropriate  glucose  level  in  the  blood.  They  can  also  send  an  alarm  to  the  wearer  when  the  blood  glucose  level  falls  outside 
 acceptable  levels.  The  devices  operate  on  a  single  channel,  and  do  not  have  a  listen  before  talk  (LBT)  capability  nor  are  they  frequency  agile,  as  required  by  the  MICS  rules.  3  Consequently,  DexCom  requests 
 a  waiver  of  these  rules  to  permit  it  to  manufacture  and  market,  and  for  medical  professionals  to  prescribe  and  diabetic  patients  to  use,  the  STS  and  LTS  as  currently  configured. 

 3.  Opposition  was  filed  by  Medtronic,  Inc.  (Medtronic),  the  developer  of  a  variety  of  medical  implant  devices,  including  implanted  monitoring  and  communications  devices  for  cardiac 
 patients  that  comply  fully  with  the  MICS  rules.  4  Comments  supporting  DexComs  request  were  filed  by  the  Juvenile  Diabetes  Research  Foundation  (JDRF);  Biotronik,  a  maker  of  other  implantable  medical 

 1  Public  Notice,  June  15,  2005,  DA  05-  1670. 
 2  MICS  operates  at  402-  405  MHz,  and  is  governed  by  Part  95,  Subpart  I  of  the  Commissions  rules 
 (47  C.  F.  R    95.  1201ff;  also  47  C.  F.  R.    95.  628).  3 
 47  C.  F.  R.    95.1211.  4 
 Meditronic  also  makes  insulin  pumps  and  a  monitor  for  diabetics  that  communicate  on  non-  MICS  frequencies. 
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 devices  with  transmitters;  and  AMI  Semiconductors,  Inc.  (AMI),  a  provider  of  integrated  circuits  to  the  medical  industry. 
 II.  BACKGROUND 
 4.  In  1999,  the  Commission  established  the  MICS  rules  to  allow  the  operation  of  radio  transmitters  that  support  the  diagnostic  and/  or  therapeutic  functions  associated  with  implanted  medical 

 devices  to  enable  individuals  and  medical  practitioners  to  utilize  potential  life-  saving  medical  technology  without  causing  interference  to  other  users  of  the  spectrum.  5  The  Commission  determined  that  the  402- 
 405  MHz  band  is  particularly  well  suited  for  this  service,  due  to  the  signal  propagation  characteristics  in  the  human  body,  the  relative  dearth  of  other  users  of  the  band,  the  compatibility  of  the  MICS  service  with 
 the  incumbent  users  of  the  band,  and  its  use  internationally  for  this  purpose.  6  To  avoid  harming  other  users  of  the  frequency  band,  MICS  was  provided  a  secondary  allocation.  The  402-  405  MHz  band  was, 
 and  remains,  allocated  on  a  primary  basis  to  Federal  Government  uses,  including  Meteorological  Aids  Service  (Metaids),  the  Meteorological  Satellite  Service,  and  the  Earth  Exploration  Satellite  Service.  7  The 
 Commission  adopted  technical  rules  for  the  MICS  specifically  designed  to  protect  these  incumbent  Federal  services,  as  well  as  to  ensure  compatibility  among  multiple  MICS  devices  and  users.  8  These  rules 
 establish  a  channel  bandwidth  of  300  kHz  for  this  service  within  the  allotted  bandwidth,  9  provide  for  frequency  sharing  and  cooperation  in  the  selection  and  use  of  channels,  10  and  establish  specific  guidelines 
 for  frequency  monitoring  prior  to  transmission  by  implant  programmer/  control  transmitters.  11  12  Given  these  protections,  the  National  Telecommunications  and  Information  Administration  (NTIA), 
 representing  the  incumbent  Federal  user  entitled  to  exclusive  use  of  this  band,  interposed  no  objection  to  this  allocation.  13 

 5.  In  2003,  the  Commission  found  that  another  implanted  medical  device  (a  cardiac  pacemaker  with  a  transmitter  for  monitoring  data  concerning  the  heart)  that  operates  similarly  to  the 
 subject  devices    at  very  low  power  with  periodic,  brief  transmissions  in  the  MICS  band,  lacking  a  listen-before-  talk  function  and  frequency  agility    did  not  comply  with  the  Commissions  rules  when  sending 

 5  Report  and  Order  in  WT  Docket  No.  99-  66  (Amendment  of  Parts  2  and  95  of  the  Commissions  Rules  to  Establish 
 a  Medical  Implant  Communications  Service  in  the  402-  405  MHz  Band)  (  MICS  Order),  14  FCC  Rcd,  21040  (1999). 

 6  Id.  at  21042-  43. 
 7  In  this  band,  Metaids  currently  operates  radiosondes,  which  are  automatic  transmitters,  usually  carried  on  an 
 aircraft,  free  balloon,  kite,  or  parachute,  which  transmit  meteorological  data  during  their  journey  through  the  atmosphere.  (See  47  C.  F.  R.    2.1.) 

 8  Id.  at  21046. 
 9  47  C.  F.  R.    95.628(  c),  (d). 
 10  47  C.  F.  R.    95.1211. 
 11  47  C.  F.  R.    95.625(  a). 
 12  The  Commission  also  provided  that  a  MICS  device  could  transmit  without  prior  frequency  monitoring,  pursuant 
 to  a  non-  radio  frequency  actuation  signal  generated  by  a  device  external  to  the  body  (manual  activation)  (47  C.  F.  R.    95.  1209(  b)),  or  in  response  to  a  medical  implant  event  (47  C.  F.  R.    95.  628(  b),  95.  1209(  b)).  These  functions  are 

 not  the  subject  of  the  instant  waiver  request.  13 
 NTIA  is  responsible  for  managing  the  Government  portion  of  the  Table  of  Frequency  Allocations.  In  bands  shared  between  Federal  and  non-  Federal  Government  services,  the  Commission  and  NTIA  operate  under  a  long-standing 

 coordination  agreement.  See  Manual  of  Regulations  and  Procedures  for  Federal  Radio  Frequency  Management,  May  2005  Revision,  Sec.  2.4.1. 
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 regular,  pre-  programmed  transmissions.  14  Subsequently,  however,  the  Commission  granted  a  temporary  waiver  for  this  device,  finding  that  the  device  could  not  be  made  to  comply  with  the  MICS  rules  and  still 
 effectively  serve  patients  at  that  time  or  in  the  near  future,  and  that  the  minimal  risk  of  harmful  interference  to  or  from  the  device  was  outweighed  by  the  significant  medical  benefits  that  the  device 
 could  immediately  provide  with  existing  technology.  15 
 6.  On  July  15,  2005,  Medtronic  filed  a  Petition  for  Rulemaking  proposing  that  a  new  Medical  Data  Service  (MEDS)  be  established  to  operate  on  a  secondary  basis  on  spectrum  adjacent  to  the 

 MICS  spectrum,  to  accommodate  simple  implanted  and  body-  worn  medical  devices  that  are  transmit-  only  and  are  not  frequency  agile.  The  Commission  has  issued  a  public  notice  seeking  comment  on  that 
 proposal.  16 
 III.  PLEADINGS 
 7.  DexCom  states  that  diabetes  is  a  serious  and  costly  health  problem  in  the  United  States  and  worldwide.  It  contends  that  maintaining  the  proper  blood  glucose  level  is  a  critical  element  in 

 controlling  diabetes,  and  that  a  number  of  factors,  anticipated  and  unanticipated,  can  affect  blood  glucose,  so  that  constant  monitoring  is  a  necessary  prerequisite  for  proper  maintenance.  It  notes  that  monitoring  is 
 currently  performed  by  a  patient  sticking  his/  her  finger  to  draw  a  small  amount  of  blood  for  testing,  and  asserts  that  this  method  is  inconvenient,  painful,  and  difficult  to  conduct  and  interpret  properly.  DexCom 
 submits  there  is  a  great  public  need  for  implantable  blood  glucose  sensors  which  can  provide  continuous,  reliable  blood  glucose  information  to  help  each  patient  monitor  his/  her  condition,  and  manage  his/  her  diet, 
 activity,  and  medication  accordingly. 
 8.  DexCom  states  that  the  STS  and  LTS  17  are  designed  to  provide  this  continuous  monitoring  function.  These  implant  devices  include  sensors  that  obtain  blood  glucose  measurements  and 

 transmit  them  every  five  minutes  to  a  receiver  carried  by  the  patient.  A  patient  can,  at  any  time,  access  information  on  his/  her  current  blood  glucose  level  and  a  chart  of  recent  levels,  to  determine  not  only  the 
 current  level  but  also  how  well  the  blood  glucose  level  is  being  maintained.  In  addition,  an  alarm  will  sound  with  each  periodic  transmission  when  blood  glucose  becomes  too  high  or  too  low,  and  repeat  with 
 each  subsequent  periodic  transmission  until  the  condition  is  corrected.  DexCom  claims  that  clinical  studies  show  that  its  monitoring  system  increases  the  amount  of  time  that  a  patient  spends  at  his/  her  target 
 blood  glucose  level  by  88%. 
 9.  DexCom  asserts  that  there  is  no  realistic  chance  of  interference  from  or  to  the  DexCom  STS  and  LTS  devices.  It  states  that  the  devices  operate  at  very  low  power  levels,  peaking  at 

 approximately  -20dBm  conducted,  for  an  operating  range  of  approximately  five  feet,  and  that  they  transmit  on  a  single  frequency  and  for  only  6-  9  milliseconds  every  five  minutes.  Accordingly,  DexCom 
 argues,  there  is  virtually  no  chance  of  interference  to  other  MICS  devices.  In  addition,  DexCom  states  that  its  system  includes  cyclic  redundancy  and  unique  identification  codes,  and  the  receiver  is  on  only 

 14  In  re  Biotronik,  Inc.  (Philos  MO&  O),  18  FCC  Rcd.  3027  (2003).  This  decision  affirmed  on  review  the  earlier 
 action  of  the  Office  of  Engineering  and  Technology  (OET)  that  found  that  a  regular  periodic  transmission  violated  the  MICS  rules. 

 15  In  re  Biotronik,  Inc.  (Biotronik  Order),  19  FCC  Rcd.  4208  (2004).  Medtronic  opposed  the  earlier  grant  of 
 equipment  authorization  and  the  request  for  waiver  for  the  Biotronik  Philos  DR-  T,  on  the  basis  that  the  periodic  operation  of  the  device  without  LBT  functionality  violates  the  MICS  rules. 

 16  Public  Notice,  August  24,  2005,  Report  No.  2725  (RM-  11271). 
 17  The  STS  uses  a  separate  injectible  probe  that  must  be  replaced  every  several  days  (the  transmitter  to  which  it  is 
 attached  is  more  permanent);  the  LTS  is  a  more  complete  monitoring  unit  that  is  fully  implanted  and  remains  for  up  to  one  year. 
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 when  the  transmitter  is  transmitting,  so  that  the  integrity  of  the  data  in  each  transmission  is  ensured.  It  relates  that  if  a  transmission  is  blocked  or  missed,  that  event  is  included  in  the  data  available,  and  any 
 such  isolated  failures  will  not  compromise  the  utility  of  the  trend  data  in  a  manner  that  would  seriously  affect  the  health  or  safety  of  the  user. 

 10.  DexCom  claims  that  a  rule  waiver  is  necessary  in  order  to  provide  this  therapeutic  tool  to  diabetics  because  technology  does  not  exist  to  allow  it  to  create  an  effective  and  practical  system  that 
 incorporates  LBT  technology  in  these  devices.  According  to  DexCom,  the  unidirectional  circuitry  of  the  STS  and  LTS  allows  for  a  compact  implant  design  which  makes  the  device  more  readily  implantable  and 
 more  stable  when  implanted,  as  is  critical  for  accurate  reading  of  blood  glucose  levels.  DexCom  also  states  that  this  design,  importantly,  provides  for  a  longer  battery  life,  a  critical  factor  for  an  implantable 
 device. 
 11.  Dexcom  contends  that  a  waiver  would  be  consistent  with  the  underlying  purpose  of  the  MICS  rules,  which  it  characterizes  as  making  the  diagnostic  and  therapeutic  benefits  of  medical  implant 

 devices  available  to  the  public  while  avoiding  harmful  interference.  In  this  regard,  DexCom  cites  the  prior  grant  of  a  waiver  by  the  Commission  to  Biotronik  for  cardiac  implant  devices  to  operate  using 
 periodically  scheduled  transmissions  without  a  LBT  capability.  18  DexCom  appends  letters  avowing  the  benefits  of  the  STS  and  LTS  devices  from  Dr.  Lois  Jovanovic  of  the  the  Sansum  Diabetes  Research 
 Institute  at  the  University  of  California  at  Santa  Barbara,  from  Dr.  Steve  Edelman  of  the  Veterans  Affairs  Medical  Center  at  the  University  of  California  at  San  Diego,  and  from  Dr.  Sherwyn  Schwartz,  founder 
 and  medical  director  of  the  Diabetes  and  Glandular  Disease  Clinic  of  San  Antonio,  Texas.  Each  of  these  doctors  describes  his/  her  extensive  experience  and  expertise  in  the  fields  of  diabetes  research  and 
 treatment,  and  attests  to  DexComs  claims  as  to  the  critical  importance  of  regular  blood  glucose  monitoring  in  controlling  diabetes,  and  the  desirability  of  a  device  such  as  the  STS  or  LTS  to  accomplish 
 this. 
 12.  In  support  of  the  waiver  request,  the  JDRF  underscores  the  potential  for  positive  impact  that  continuous  glucose  sensing  technologies  may  have  for  diabetes  patients,  and  asserts  that  a  number  of 

 studies  have  shown  that  tighter  glucose  control  can  reduce  the  costly  and  debilitating  complications  associated  with  diabetes.  Biotronik  also  asserts  that  the  DexCom  devices  can  improve  the  well  being  of 
 millions  of  Americans,  and  agrees  with  DexCom  that  there  is  no  potential  for  interference  between  the  subject  devices  and  other  MICS  users.  It  contends  that  a  LBT  function  cannot  be  achieved  without 
 significant  sacrifice  to  both  battery  longevity  and  the  size  of  the  device,  and  that  each  of  these  design  considerations  are  critical  for  implantable  medical  devices.  AMI  also  asserts  that  DexComs  implantable 
 continuous  glucose  monitoring  system  provides  significant  medical  benefits.  As  a  provider  of  specific  integrated  circuits  and  standard  products  to  the  medical  marketplace,  AMI  insists  that  such  frequent 
 monitoring  imposes  demands  on  the  battery  that  are  inconsistent  with  a  LBT  protocol.  A  larger  battery  or  more  frequent  surgeries,  it  surmises,  will  reduce  the  number  of  patients  that  will  use  such  a  device.  It, 
 too,  concludes  that  the  combination  of  low  duty  cycle,  transmission  time,  and  range  should  pose  little  risk  of  interference. 

 13.  Medtronic  opposes  the  waiver  request,  contending  that  a  waiver  is  unnecessary,  as  other  spectrum  is  available  for  this  device  that  would  permit  it  to  operate  within  the  Commissions  rules.  It  also 
 claims  that  other  medical  device  manufacturers  are  developing  products  that  comply  with  the  rules,  contrary  to  DexComs  claim  that  a  rule  waiver  is  necessary  to  design  and  manufacture  suitable  medical 
 implant  devices.  It  submits  that  ultra-  low  power  MICS  transceiver  chips  are  now  available  from  a  number  of  sources,  and  that  compliance  with  the  LBT  requirement  is  fully  within  the  state  of  the  art.  It 
 contends  that  grant  of  this  waiver  would  compromise  the  integrity  of  the  MICS  service  as  more  and  more  patients  rely  on  intelligent  medical  implants  to  convey  time-  sensitive  information.  It  also  asserts  that 

 18  Biotronik  Order,  supra. 
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 many  international  regulatory  bodies  call  for  smart  radio  technology  for  medical  implant  communications  devices  operating  at  402-  405  MHz,  and  that  LBT  is  a  cornerstone  of  the  MICS.  Medtronic  also 
 complains  that  DexComs  failure  to  disclose  key  RF  system  operating  parameters  or  to  provide  a  complete  description  of  its  sensor  systems  makes  it  impossible  to  assess  fully  the  interference  impact  of 
 the  STS  and  LTS  on  other  low-  power  medical  devices,  and  asserts  that  the  DexCom  device  would  be  subject  to  receiving  interference.  Medtronic  also  argues  that  the  transmitter  portion  of  the  devices  rests 
 on  top  of  the  skin,  and  thus  is  not  within  the  purview  of  the  MICS  rules.  It  urges  the  Commission,  if  it  does  grant  a  waiver,  to  require  that  DexCom  use  spectrum  directly  adjacent  to  the  MICS  spectrum,  and 
 proposes  several  conditions.  Specifically,  it  asks  that  we  limit  the  waiver  to  two  years;  that  we  apply  it  only  to  subcutaneous  and  transcutaneous  equipment  and  exclude  equipment  that  is  entirely  external  to  the 
 body;  that  we  limit  operation  to  non-  life-  critical,  non-  emergency  communications;  that  we  require  that  medical  professionals  and  patients  be  given  prior  notice  of  the  potential  of  interference  from  Metaids 
 radiosondes  along  with  instruction  on  how  to  mitigate  interference;  and  that  we  require  system  administrators  to  give  medical  professionals  and  patients  notice  of  each  of  the  conditions  placed  on  the 
 DexCom  equipment.  Medtronic  notes  that  it  has  filed  a  petition  for  rulemaking  to  establish  the  Medical  Data  Service  (MEDS)  at  401-  402  and  405-  406  MHz  for  just  such  devices.  19 

 IV.  DISCUSSION 
 14.  We  find  that  a  temporary  waiver  for  the  DexCom  STS  and  LTS  to  operate  as  currently  designed  is  warranted.  There  is  good  cause  for  granting  this  waiver,  and  it  is  in  the  public  interest  to  do 

 so.  20  To  deny  the  waiver  would  frustrate  the  underlying  purpose  of  the  rules  and  DexCom  and  the  diabetic  patients  its  devices  will  serve  have  no  reasonable  alternative  to  obtain  the  important  benefits 
 afforded  by  the  DexCom  devices  at  this  time.  21  The  periodic/  automatic  transmissions  of  the  STS  and  LTS  will  assist  diabetics  in  maintaining  their  blood  glucose  levels,  a  very  significant  therapeutic  benefit  that 
 was  a  basis  for  the  establishment  of  the  MICS  rules,  without  posing  an  undue  potential  for  interference.  22  This  waiver  is  granted  for  three  years,  or  until  completion  of  any  rule  making  the  Commission  may 
 undertake,  whichever  is  later.  If  rules  are  adopted  with  which  the  STS  and  LTS  comply,  the  waiver  will  become  moot.  If  rules  are  adopted  that  would  require  modifications  to  the  STS  and  LTS,  such  as  a 
 change  in  power  or  frequency,  DexCom  will  have  one  year  from  the  effective  date  of  such  rules  to  bring  its  devices  into  compliance.  In  any  event,  any  devices  implanted  pursuant  to  the  instant  waiver  may 
 continue  operating  until  the  end  of  their  useful  life. 
 15.  The  significant  medical  value  of  these  devices  as  presently  constituted  for  current  diabetic  patients  is  a  compelling  factor  in  our  consideration.  The  substantial  public  interest  in  making  a 

 blood  glucose  monitoring  system  available  is  uncontested.  According  to  the  un-  refuted  statements  of  DexCom  and  its  supporters  in  this  waiver  request,  close  to  20  million  Americans  and  over  170  million 
 people  worldwide  suffer  from  diabetes,  and  it  is  the  fifth-  leading  cause  of  death  by  disease  in  the  United  States.  Diabetes  and  complications  from  diabetes,  including  heart  disease,  stroke,  loss  of  eyesight,  loss  of 
 kidney  function,  and  amputation  of  limbs,  is  presently  estimated  at  $132  billion  per  year,  including  $90  billion  in  direct  medical  care  costs.  While  there  is  no  known  cure  for  diabetes,  a  critical  goal  of  medical 
 care  is  to  manage  patients  blood  sugar  levels  to  control  the  disease.  Regular  monitoring  is,  in  turn,  a  critical  element  of  achieving  this.  Unfortunately,  two-  thirds  of  Type  2  diabetics  23  in  America  do  not  have 

 19  See  para.  6,  supra. 
 20  See  WAIT  Radio  v.  FCC,  459  F.  2d  1203,  1207  (D.  C.  Cir.  1972). 
 21  See  47  C.  F.  R.    1.925. 
 22  MICS  Order,  supra  at  21040. 

 23  Type  2  diabetes  is  the  most  common  form  of  diabetes,  in  which  either  the  body  does  not  produce  enough  insulin 
 or  the  cells  ignore  the  insulin.  Without  insulin,  the  body  is  unable  to  use  sugar,  which  is  the  basic  fuel  for  the  cells  (continued....) 
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 adequate  control  of  their  blood  glucose  levels.  The  importance  of  regular  monitoring  and  maintenance  is  attested  to  by  several  experts  in  the  field,  and  by  several  studies  referred  to  by  DexCom.  In  addition, 
 DexCom  has  submitted  data  derived  from  clinical  trials  which  compare  the  blood  sugar  levels  of  a  patient  using  the  traditional,  and  less  frequent,  finger  stick  method  with  the  continuous  data  available  from  the 
 DexCom  system;  this  data  demonstrate  a  dramatic  improvement  with  continuous  monitoring.  We  also  take  cognizance  of  DexComs  statement  that  the  Federal  Drug  Administration  is  expediting  its  review  of 
 the  devices  in  view  of  the  health  benefits  they  promise. 
 16.  DexCom  has  also  demonstrated  that  there  is  little  risk  of  harmful  interference  caused  by  or  occurring  to  the  devices.  While  Medtronic  charges  that  it  does  not  have  complete  information 

 regarding  the  RF  characteristics  of  the  devices,  such  as  their  exact  power  level,  so  as  to  assess  their  potential  to  interfere  with  MICS  devices,  we  find  the  information  available  is  sufficient  to  make  this 
 determination  when  considered  in  the  light  least  favorable  to  DexCom.  The  STS  and  LTS  will  operate  on  only  one  frequency  (402.142  MHz  +/-  40  kHz),  occupying  only  120  kHz  of  bandwidth,  at  a  power  level 
 less  than  that  permitted  in  the  MICS  band  (-  20dBm  conducted),  24  and  for  only  6-  9  milliseconds  every  five  minutes.  This  combination  of  bandwidth,  power,  and  duration  make  the  likelihood  of  causing 
 interference  virtually  nil.  Given  the  proximity  of  the  receiver  to  the  transmitter,  it  is  also  highly  unlikely  that  another  MICS  device  will  be  sufficiently  close  to  cause  interference  to  a  DexCom  device  while 
 attempting  to  transmit  at  the  same  moment  and  on  the  same  frequency  as  a  DexCom  device.  The  likelihood  of  interference  to  a  DexCom  receiver  that  would  obstruct  its  basic  function  is  even  further 
 remote,  given  the  frequency  of  data  transmissions  and  the  non-  critical  nature  of  an  individual  transmission.  If  an  undesired  signal  is  received,  the  data  will  not  be  corrupted,  but  simply  blocked  from 
 reception.  If  a  transmission  is  not  received  due  to  interference,  the  loss  of  that  data  point,  one  of  288  per  day,  is  not  critical  to  the  overall  monitoring  function  provided  by  the  monitor.  25  If  that  particular  reading 
 or  datum  warrants  an  alarm,  the  alarm  will  be  resent  with  each  subsequent  periodic  transmission  until  the  patients  blood  glucose  level  returns  to  an  acceptable  level,  and  while  prompt  response  by  the  patient  is 
 desirable,  a  delay  of  minutes  is  not  critical.  We  note,  too,  that  the  National  Telecommunications  and  Information  Administration  (NTIA),  which  represents  the  primary,  licensed,  users  of  this  band  and  is 
 concerned  with  any  possible  negative  effects  of  its  operation,  has  raised  no  objection  to  this  waiver. 
 17.  DexCom  has  also  shown  that  a  waiver  of  the  MICS  rules  is  necessary  for  its  device  to  function  effectively.  The  unidirectional  circuitry  of  the  device  allows  for  a  compact  and  lightweight 

 design  that  will  remain  in  place  for  accurate  sensing,  with  a  relatively  long  life.  Moreover,  keeping  down  the  cost  of  the  system  will  make  it  accessible  to  more  users.  While  Medtronic  asserts  that  compliant 
 technology  exists,  the  examples  it  provides  are  either  not  presently  available  or  do  not  appear  suitable  for  the  device  that  DexCom  has  developed.  The  existence  of  a  few  other  medical  transmit  devices  that 
 operate  at  other  frequencies  on  an  unlicensed  basis  does  not  undercut  this  conclusion.  While  there  is  other  spectrum  in  which  unlicensed  devices  can  operate,  the  spectrum  specifically  suggested  by 
 Medtronic  26  has  restrictions  that  are  inappropriate  for  the  subject  devices  or  are  sufficiently  congested  to  pose  a  risk  that  the  very  low  powered  transmissions  of  the  subject  devices  would  be  at  greater  risk  of 
 receiving  interference;  moreover,  they  would  have  no  interference  protection  from  the  plethora  of  other  devices  operating  in  those  bands.  Neither  do  we  see  a  need  to  require  DexCom  to  redesign  its  equipment 

 (...  continued  from  previous  page)  in  the  body,  and  insulin  takes  the  sugar  from  the  blood  into  the  cells.  When  sugar  (glucose)  builds  up  in  the  blood 
 instead  of  going  into  cells,  it  can  cause  two  problems:  cells  are  immediately  starved  for  energy,  and  over  time,  high  blood  glucose  levels  damage  your  eyes,  kidneys,  nerves  or  heart  and  lead  to  deterioration  of  the  feet  and  legs. 
 24  47  C.  F.  R.    95.639  permits  a  maximum  EIRP  of  25  microwatts. 
 25  We  note  that  FDA  will  require  that  patients  continue  to  finger  prick,  to  ensure  the  availability  of  blood  glucose 
 information  in  the  event  of  a  malfunction  of  the  device.  26 
 Medtronic  cites  devices  that  operate  under  Part  15  of  the  FCCs  rules  at  315  MHz,  418  MHz,  and  916.5  MHz. 
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 to  use  alternative  spectrum  adjacent  to  the  MICS  spectrum,  as  suggested  by  Medtronic.  Such  a  change  would  not  obviate  the  need  for  a  waiver  and,  as  indicated  above,  we  do  not  anticipate  a  realistic  likelihood 
 of  interference,  at  least  in  the  timeframe  encompassed  by  this  waiver.  Moreover,  given  the  potential  for  a  rulemaking  proceeding  addressing  medical  telemetry  devices  and  the  spectrum  at  issue,  it  would  be 
 premature  to  move  these  devices  off  the  frequency  currently  designated  for  medical  implant  communications. 

 18.  Medtronics  argument  that  DexCom  cannot  invoke  the  MICS  rules  because  the  transmitter  for  the  STS  lies  above  the  skin  is  unavailing.  Section  95.1201  of  our  rules  provides  that  [  a] 
 person  is  permitted  to  operate  medical  implant  transmitters  connected  to  medical  implant  devices  that  have  been  implanted  in  that  person.  27  The  phrase  that  have  been  implanted  can  modify  medical 
 implant  devices  or  it  can  modify  medical  implant  transmitters  connected  to  medical  implant  devices.  The  text  of  the  MICS  Order  is  not  conclusive  in  this  regard.  We  do  note  that  the  term  medical  implant 
 transmitter  is  defined  as  [  a]  MICS  transmitter  that  operates  or  is  designed  to  operate  within  a  human  body  in  the  appendix  to  subpart  E  of  Part  95.  28  In  any  event,  DexCom  is  seeking  waiver  of  the  MICS 
 rules,  not  to  invoke  the  MICS  rules,  so  that  a  determination  of  this  issue  is  not  required  in  order  to  grant  the  waiver  request.  We  will  clarify  this  issue  in  any  future  proceeding  on  medical  implant  devices. 

 19.  Finally,  most  of  the  conditions  sought  by  Medtronic  are  variously  inappropriate  or  unnecessary.  We  reject  Medtronics  request  that  we  restrict  the  waiver  to  subcutaneous  and 
 transcutaneous  transmitters  for  the  reasons  indicated  above.  We  also  reject  its  request  for  a  two-  year  limit.  Instead,  we  are  making  the  waiver  dependent  on  the  timing  and  outcome  of  any  relevant  rule 
 making  we  may  conclude,  with  a  minimum  of  three  years  as  a  reasonable  timeframe  for  successfully  marketing  and  implementing  use  of  the  subject  devices  in  their  current  configuration.  There  is  no 
 evidence  that  the  MICS  band  would  become  so  congested  in  that  time  that  the  STS  and  LTS  would  pose  an  undue  interference  risk  if  the  current  rules  are  maintained.  Moreover,  this  period  will  provide  a  better 
 picture  of  the  utility  and  interference  potential  of  these  devices  should  a  dispositive  rule  making  not  conclude  in  the  interim  and  a  subsequent  waiver  be  presented  for  consideration.  Its  proposed  limitation 
 regarding  the  devices  operational  characteristics  are  necessarily  observed  in  granting  this  waiver  for  the  specific  subject  devices.  Proposed  warnings  regarding  potential  interference  from  radiosondes  are  largely 
 unnecessary,  given  the  insignificance  of  such  interference  when  it  might  occur.  The  other  conditions  we  do  impose  (below)  do  not  comprise  pertinent  information  for  medical  professionals  or  patients  using  the 
 subject  devices. 
 20.  We  recognize  here,  as  we  did  in  granting  the  Biotronik  waiver,  that  this  waiver  request  and  our  action  herein  may  presage  a  need  or  a  reasonable  desire  for  additional  medical  implant  devices 

 that  would  operate  at  variance  with  the  current  MICS  rules.  29  As  noted  above,  we  have  very  recently  accepted  comment  on  just  such  a  proposal  by  Medtronic,  and  the  waiver  granted  herein  is  subject,  after  a 
 prescribed  transition  period  to  modification  based  on  any  rules  we  may  adopt. 
 21.  For  the  above  reasons,  we  will  grant  this  waiver  for  a  period  of  three  years,  or  until  one  year  after  completion  of  any  rule  making  the  Commission  may  undertake  regarding  medical  implant 

 devices,  whichever  is  later.  Additionally,  we  will  condition  the  continued  implantation  of  the  devices  covered  by  this  waiver  on  their  non-  interference  with  other  MICS  devices  and  with  the  primary  users  of 
 this  spectrum.  Should  a  pattern  of  interference  develop  that  is  traceable  to  devices  operating  pursuant  to 

 27  47  C.  F.  R.    95.1201. 
 28  See  Appendix  1  to  Subpart  E  of  Part  95    Glossary  of  Terms. 
 29  Biotronik  Order,  supra  at  4214. 
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 this  waiver,  we  will  rescind  the  waiver  to  prohibit  the  implantation  of  additional  devices.  30  This  period  of  time  should  provide  an  adequate  window  for  the  successful  manufacture  and  utilization  of  the  subject 
 devices  while  we  contemplate  changes  to  the  medical  implant  rules.  Also,  during  this  period,  advances  in  technology  may  improve  the  operability  and  availability  of  listen-  before-  talk  implantable  devices, 
 obviating  the  need  for  a  waiver  for  future  devices. 
 V.  ORDERING  CLAUSES 
 22.  Accordingly,  pursuant  to  Section  1.925  of  the  Commissions  rules  (47  C.  F.  R.    1.925),  DexComs  petition  for  waiver  of  the  MICS  rules  IS  GRANTED  for  the  manufacture  and  use  of  the  STS 

 and  LTS  blood  glucose  monitoring  systems,  as  described  in  this  Order,  subject  to  the  following  conditions: 

 Devices  authorized  by  this  waiver  will: 
 (a)  Occupy  no  more  than  120  kHz  of  bandwidth  at  402.  142  MHz  +/-  40  kHz; 
 (b)  Provide  transmissions  that  do  not  exceed  10  milliseconds  each; 
 (c)  Employ  a  duty  cycle  that  does  not  exceed  one  transmission  every  five  minutes; 

 This  waiver  does  not  relieve  DexCom  of  the  requirement  to  avoid  interference  to  other  MICS  devices  and  to  the  licensed  primary  users  of  this  band. 
 This  waiver  does  not  provide  the  subject  devices  with  protection  of  transmissions  by  authorized  users  of  the  band. 
 This  waiver  expires  three  years  from  the  release  date  of  this  Order  or  until  one  year  after  completion  of  any  rule  making  the  Commission  may  undertake,  whichever  is  later.  After  that  time,  LTS 
 devices  implanted  pursuant  to  this  waiver  may  continue  to  operate,  but  use  of  STS  devices  under  this  waiver  must  cease  and  no  additional  LTS  devices  can  be  implanted  in  patients  pursuant  to  this  waiver. 

 FEDERAL  COMMUNICATIONS  COMMISSION 

 Marlene  H.  Dortch  Secretary 

 30  We  would  not,  of  course,  require  the  removal  of  LTS  devices  appropriately  implanted  pursuant  to  this  waiver;  we 
 would  require  discontinuation  of  use  of  STS  devices. 
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