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 Federal  Communications  Commission  DA  06-  2316 
 Before  the  Federal  Communications  Commission 
 Washington,  D.  C.  20554 

 In  the  Matter  of 
 Respironics,  Inc.  and  Boston  Scientific  Corporation 

 Requests  for  Waiver  of  Section  15.205  of  the  Commissions  Rules  to  Permit  the  marketing  and 
 operation  of  certain  medical  communications  devices  that  operate  in  the  90-  110  kHz  band 

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 ET  Docket  No.  05-  331 

 ORDER 
 Adopted:  November  16,  2006  Released:  November  16,  2006 
 By  the  Chief,  Office  of  Engineering  and  Technology: 

 I.  INTRODUCTION 
 1.  By  this  action,  we  grant  the  Requests  for  Waiver  filed  by  Respironics,  Inc.  (Respironics)  on  October  28,  2005  and  by  Boston  Scientific  Corporation  (Boston  Scientific)  on  June  6,  2006,  to  permit 

 the  marketing  and  operation  of  certain  medical  communications  devices  that  are  not  in  compliance  with  the  restricted  band  provisions  in  Section  15.205  of  the  Commissions  rules.  1  Specifically,  we  permit 
 Respironics  to  market,  for  a  limited  period  of  time  and  in  limited  number,  its  ActiReader  devices,  and  we  permit  Boston  Scientific  to  manufacture  and  market,  for  a  limited  period  of  time,  its  implantable  cardiac 
 rhythm  management  devices.  We  find  that  there  is  good  cause  to  grant  these  waivers,  and  that  the  public  interest  will  be  served  by  doing  so.  In  this  regard,  we  conclude  that  grant  of  these  waivers  will  afford 
 medical  patients  the  important  health  benefits  provided  by  the  Respironics  and  Boston  Scientific  devices  for  which  there  currently  are  no  reasonable  alternatives  and  would  not  contravene  the  underlying 
 purposes  of  our  rules  for  unlicensed  devices. 
 II.  BACKGROUND 
 2.  Under  Section  15.205  of  the  Commissions  rules  for  unlicensed  radio  devices,  intentional  radiators  generally  are  not  permitted  to  operate  in  certain  sensitive  or  safety-  related  frequency  bands  that 

 are  designated  as  restricted  bands.  The  restricted  bands  listed  in  Section  15.  205  are  bands  employed  by  radio  services  that  must  function,  as  a  nature  of  their  operation,  using  extremely  low  received  signal 
 levels.  These  systems  may  be  passive,  such  as  radio  astronomy,  or  active,  such  as  satellite  down  links  and  wildlife  tracking  systems. 

 1  47  C.  F.  R.    15.205. 
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 3.  Respironics  develops,  manufactures  and  distributes  products  and  programs  around  the  world  that  manage  sleep  disordered  breathing,  chronic  obstructive  pulmonary  disease,  asthma,  allergies  and 
 sinusitis,  infant  jaundice,  apnea,  heart  failure,  and  restrictive  lung  disorders.  2  Respironics  recently  acquired  another  company  that  develops  and  sells  sleep  and  physiological  monitoring  products, 
 including  a  series  of  activity  monitors  that  are  used  to  monitor  sleep  patterns,  physical  activity/  calorie  expenditures,  and  other  indicia  of  human  activity  and  behavior.  These  last  products  are  the  subject  of 
 this  waiver  consideration.  In  this  family  of  products,  an  ActiWatch  is  worn  by  a  patient/  subject  and  is  equipped  with  a  highly  sensitive  accelerometer  and  a  data  recorder.  The  collected  data  is  periodically 
 transferred  from  the  ActiWatch  to  an  ActiReader  via  a  low-  power,  short-  range  wireless  link  established  by  emissions  from  the  ActiReader.  This  link  is  active  only  during  periods  of  such  data 
 transfer.  The  data  is  then  downloaded  from  the  ActiReader  to  a  storage  device,  typically  a  computer.  The  resulting  activity  record  can  be  used  to  study  sleep/  wake  patterns,  sleep  disorders,  circadian  rhythm 
 disorders,  basic  activity  levels,  and  similar  conditions.  With  this  information,  practitioners  can  diagnose  ailments  and  design  treatments  accordingly. 

 4.  The  ActiWatch  and  ActiReader  devices  are  designed  to  communicate  using  the  fundamental  frequency  of  104  kHz,  which  is  within  the  90-  110  kHz  restricted  band  that  is  prohibited  from  use  by 
 unlicensed  devices  under  Section  15.205(  a)  of  our  rules.  This  band  is  reserved  for  use  by  the  Federal  Government,  and  is  currently  used  by  LORAN-  C,  a  radionavigation  system  provided  by  the  Federal 
 Government  for  civil  marine  use  and  en  route  supplemental  navigation  aid  for  civil  aviation.  Respironics  contends  that  its  ActiReader  devices  pose  a  negligible  risk  of  causing  interference,  as  their  RF  emissions 
 are  50  dB  below  the  level  permitted  for  spurious  emissions  by  intentional  radiators  in  the  subject  restricted  band.  It  submits  that  emissions  from  ActiReader  units  should  not  be  detectable  beyond  a  few 
 millimeters  from  the  device.  3  Moreover,  according  to  Respironics,  such  emissions  generally  occur  only  a  few  times  a  day  for  each  ActiReader  unit,  4  occur  in  controlled  settings  in  a  limited  number  of  predictable 
 locations  under  the  supervision  of  a  trained  operator,  and  last  for  only  a  few  seconds  on  each  occasion.  Respironics  seeks  a  waiver  of  Section  15.205(  a)  5  to  permit  the  use  of  existing  ActiReaders  and  the 
 production  and  sale  of  an  additional  1,000  ActiReaders  over  the  next  18  months,  during  which  time  it  will  redesign  this  product  to  be  compliant  with  our  rules.  6 

 5.  Boston  Scientific  is  a  worldwide  manufacturer  of  medical  devices  for  cardiac  patients.  These  devices  include  implantable  pacemakers  (the  PDM  family),  cardioverter  defibrillators  (the  PD2 
 family),  and  cardiac  resynchronization  therapy  (the  Contak  Renewal  TR  family)  devices.  These  devices  deliver  electrical  stimuli  to  the  heart  when  needed  to  treat  abnormal  heart  rhythms.  They  also 
 store  information  on  a  patients  cardiac  functioning,  as  well  as  the  functioning  of  the  device  itself.  Boston  Scientific  indicates  that  the  data  collected  and  stored  in  these  devices  is  downloaded  by  inductive 

 2  Respironics  Petition  at  2. 
 3  Respironics  Petition  for  Waiver,  Exhibit  1.  Respironics  further  notes  that  ActiReader  emission  levels  are  below 
 the  noise  floor  for  many  measuring  instruments.  4 
 According  to  Respironics,  there  are  approximately  12,000  ActiWatches  and  1500  ActiReaders  in  the  field.  This  is  an  average  of  eight  Actiwatches  for  each  ActiReader,  which  suggests  that  each  ActiReader  functions,  on  average, 

 approximately  four  times  per  day  for  a  total  of  less  than  ten  seconds  per  day  per  ActiReader.  5 
 Respironics  petition  was  placed  on  public  notice  on  December  5,  2005  (Public  Notice  DA  05-  3142).  Comments  and  reply  comments  thereon  were  filed  by  Respironics  and  James  Edwin  Whedbee,  all  of  which  support  the  waiver 

 request. 
 6  We  note  that,  according  to  Respironics,  approximately  1,500  noncompliant  and  uncertified  ActiReaders  are  already 
 the  field  in  clinics,  hospitals,  and  research  labs,  and  that,  as  a  separate  matter,  the  Commission  is  considering  appropriate  enforcement  action  with  respect  to  these  devices. 
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 coupling  with  a  wand  that  is  placed  over  the  patients  chest  within  inches  of  the  implant  to  receive  extremely  low  level  transmissions.  The  devices  operational  settings  can  also  be  adjusted  through  the 
 same  process.  The  Boston  Scientific  wand  reader  devices  produce  fundamental  emissions  in  the  90-  110  kHz  restricted  band,  and  thus  violate  the  restricted  band  provisions  of  our  rules.  7  Boston  Scientific 
 states  that  it  is  now  developing  next  generation  devices  (the  Teligen,  Cognis,  and  Ingenio  families)  that  would  also  use  inductive  coupling  on  frequencies  in  the  90-  110  kHz  band,  but  only  to 
 initiate  a  communications  session  and  as  a  backup  means  of  data  communications.  It  indicates  that  these  new  devices  would  transmit  in  the  900  MHz  band  as  their  primary  means  of  data  transfer.  Boston 
 Scientific  also  submits  that  it  intends  to  develop  new  product  lines  that  will  eliminate  inductive  coupling  in  the  90-  110  kHz  band  altogether. 

 6.  Boston  Scientific  argues  that  interference  from  its  current  and  next  generation  devices  is  virtually  impossible.  It  submits  that  its  current  devices  operate  with  a  field  strength  that  is  70  dB 
 below  the  level  permitted  for  spurious  emissions,  and  that  its  next  generation  devices  will  operate  with  a  field  strength  50  dB  below  the  spurious  emissions  limit.  Boston  Scientific  states  at  these  levels  its  wands 
 for  reading  the  data  from  implantable  medical  devices  are  unlikely  to  cause  interference  to  any  incumbent  licensed  user.  8  It  further  submits  that  these  devices  operate  for  only  a  few  moments  at  a  time, 
 and  only  in  a  hospital  or  medical  clinic  setting,  away  from  other  likely  sources  or  recipients  of  interference.  Boston  Scientific  indicates  that  its  next  generation  devices  will  operate  in  the  90-  110  kHz 
 restricted  band  for  a  cumulative  total  of  about  two  seconds  per  year  per  unit.  It  notes  that  the  potential  for  interference  is  further  limited  by  the  fact  that  the  frequencies  affected  by  the  subject  devices  are  used 
 by  the  federal  government  only  for  LORAN-  C  devices,  which  are  located  in  airplanes  and  boats,  not  in  the  vicinity  of  a  hospital  or  clinic,  where  the  inductive  communications  sessions  would  typically  occur. 

 7.  Boston  Scientific  also  contends  that  it  supplies  30%  of  all  cardiac  devices  in  the  U.  S.,  and  that  taking  its  product  off  the  market  would  result  in  a  shortage  of  such  products  available  for  patients  that 
 need  them,  and  also  reduce  market  competition  in  the  field.  It  therefore  seeks  a  waiver  9  of  Section  15.205(  a)  to  permit  the  continued  manufacture  and  marketing  of  its  current  devices  and  its  next 
 generation  devices,  as  well,  until  the  development  of  non-  inductive  coupling  devices  can  be  completed  and  the  devices  can  be  introduced  into  the  market  for  use.  10  It  requests  a  two-  year  waiver  for  the  PDM 
 and  PD2  devices  and  a  three-  year  waiver  for  the  Contak  Renewal  TR  devices  while  it  brings  its  next  generation  devices  to  market.  For  the  next  generation  devices,  Boston  Scientific  requests  a  waiver  for  a 
 period  of  six  years  after  each  devices  respective  market  release  following  FDA  approval.  Such  a  waiver,  it  submits,  will  permit  Boston  Scientific  to  exit  the  band  in  an  orderly  manner  consistent  with  the 
 compelling  public  interest  in  the  availability  of  these  devices.  It  asserts  that  the  lengths  of  time  it  requests  will  ensure  the  new  devices  thorough  and  safe  development,  including  the  multiyear  period  of  testing  and 
 FDA  approval,  and  the  adequate  availability  of  replacement  devices  for  cardiac  patients  across  the  country.  With  respect  to  permitting  the  next  generation  products  that  are  not  yet  in  the  market,  Boston 
 Scientific  also  argues  that  these  products  would  at  least  greatly  reduce,  if  not  eliminate,  the  interference 

 7  See  n.  1,  supra. 
 8  Boston  Scientific  Petition  for  Waiver,  Attachment  B. 
 9  Boston  Scientifics  petition  was  not  placed  on  public  notice,  given  the  recent  Respironics  petition  which  raised 
 essentially  the  same  issue,  and  the  paucity  of  response  to  that  public  notice.  10 
 Boston  Scientific  asserts  that  approximately  85,000  people  use  these  implants  today,  and  estimates  that  another  12,500  people  would  receive  them  over  the  next  three  years  under  a  waiver.  As  a  separate  matter,  the  Commission 

 is  considering  appropriate  enforcement  action  with  respect  to  those  devices  manufactured  and  sold  without  appropriate  equipment  certification. 
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 potential  in  the  restricted  band  as  compared  to  the  current  products.  11 
 III.  DISCUSSION 
 8.  We  find  that  temporary  waivers  are  warranted  for  the  Respironics  and  Boston  Scientific  devices  considered  herein  to  operate  as  currently  designed  for  a  limited  period  of  time  while  compliant 

 devices  are  developed  and  produced.  This  is  an  unusual  and  compelling  situation,  in  which  health-  and  life-  critical  technology  is  already  being  relied  on  by  patients  and  their  caregivers,  and  there  is  little 
 likelihood  of  interference,  given  the  operational  parameters  and  location  of  use  of  each  of  the  devices  when  transmitting.  Accordingly,  there  is  good  cause  for  granting  these  waivers  and  it  is  in  the  public 
 interest  to  do  so.  12  To  deny  these  waivers  would  not  serve  the  underlying  purpose  of  the  rules,  as  it  is  unlikely  that  grant  of  the  waivers  would  lead  to  the  harm  that  the  rule  is  intended  to  avoid,  i.  e., 
 interference  to  primary  users  of  the  band.  And,  finally,  Respironics,  Boston  Scientific,  and  the  patients  their  devices  will  serve  have  no  reasonable  alternative  at  this  time  to  obtain  the  important  benefits 
 afforded  by  the  devices.  13  The  waiver  for  the  Respironcs  ActiReader  is  granted  for  12  months  from  the  release  of  this  Order.  The  waivers  for  the  Boston  Scientific  devices  are  for  various  periods  as  specified 
 below,  with  a  maximum  of  three  years  from  the  release  date  of  this  Order. 
 9.  These  temporary  waivers  only  apply  to  the  constraints  on  emissions  in  the  restricted  frequency  bands  as  specified  in  Section  15.205  of  the  Commissions  rules.  14  These  waivers  do  not 

 provide  relief  of  the  requirements  of  Section  15.5(  b).  Specifically,  the  requirement  that  interference  to  the  subject  Respironics  Inc.,  and  Boston  Scientific  Corporation  products  that  may  be  caused  by  the 
 operation  of  a  LORAN-  C  radio  station  must  be  accepted. 
 10.  Respironics.  The  Respironics  ActiReader/  ActiWatch  system  is  a  valuable  tool  for  research  into  and  treatment  of  significant  medical  ailments,  as  described  above,  and  to  our  knowledge,  there  are 

 no  alternatives  available  now  or  in  the  near  future.  Given  the  extremely  low  power,  infrequency  of  use,  locations  of  use,  and  limited  number  of  these  devices  currently  available  and  as  limited  in  the  future  by 
 our  waiver  (12  months  and  1000  units),  these  devices  pose  a  negligible  risk  of  causing  the  interference  our  rules  are  designed  to  protect.  While  it  is  apparently  possible  to  design  products  which  perform  the 
 ActiReader/  ActiWatch  functions  that  are  compliant  with  the  rules,  without  this  waiver,  Respironics  would  be  unable  to  provide  a  continuous  supply  of  this  valuable  and  unique  product  to  doctors  and 
 researchers  while  it  is  redesigning  its  product  and  manufacturing  a  new  supply.  Respironics  request  for  18  months  was  made  in  October,  2005,  and  we  can  reasonably  project  that  it  has  made  progress  in  its 
 new  design  since  that  time.  Accordingly,  we  will  permit  Respironics  to  continue  to  manufacture  and  sell  a  maximum  of  1000  ActiReaders  as  currently  designed  as  described  in  this  Order  for  a  period  of  12 
 months  after  the  release  date  of  this  Order. 
 11.  Boston  Scientific.  Boston  Scientifics  subject  cardiac  devices  provide  life-  saving  technology  to  cardiac  patients.  Their  monitoring  function,  which  is  enabled  by  the  inductive  coupling  at 

 issue,  provides  an  important  element  of  patient  care.  Moreover,  the  devices  themselves  can  be  adjusted  as  needed  through  the  communication  session.  Given  their  technical  and  operational  parameters,  these 
 devices,  too,  pose  a  negligible  likelihood  of  interference.  While  it  is  apparently  possible  to  design  and  manufacture  functionally  equivalent  devices  which  comply  with  the  rules,  as  Boston  Scientific  indicates 

 11  We  note  that  Boston  Scientific  has  filed  a  Petition  for  Rule  Making,  which  is  now  the  subject  of  an  ongoing 
 Commission  proceeding.  See,  Notice  of  Inquiry,  Notice  of  Proposed  Rulemaking,  and  Order  in  ET  Docket  No.  06-  135,  FCC  06-  103,  released  July  18,  2006,  71  FR  43682,  August  2,  2006. 

 12  See  WAIT  Radio  v.  FCC,  459  F.  2d  1203,  1207  (D.  C.  Cir.  1972). 
 13  See  47  C.  F.  R.    1.925. 
 14  See  47  C.  F.  R.    15.  205. 
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 that  it  is  in  the  process  of  doing,  the  short-  term  product  shortage  that  would  result  from  taking  the  current  devices  off  the  market  without  a  phase-  out  period  would  likely  be  detrimental  to  the  public,  and 
 specifically  medical  patients  and  their  families  who  benefit  from  their  use.  Additionally,  while  Boston  Scientifics  planned  next  generation  products  also  fail  to  comply  fully  with  the  rules  they  will  pose 
 significantly  less  interference  potential  than  the  current  devices,  despite  a  higher  field  strength,  15  because  they  will  be  operated  at  a  much  lower  duty  cycle  of  only  about  two  cumulative  seconds  per  year. 
 Accordingly,  we  believe  that  permitting  these  next  generation  products  to  replace  the  current  products  as  part  of  the  phase-  out  until  fully-  compliant  products  can  be  introduced  will  reduce  the  interference 
 potential  of  the  Boston  Scientific  cardiac  medical  products  at  issue  here.  We  note,  too,  that  the  next  generation  devices  include  improved  technology  and  design  to  improve  performance  and  enhance  patient 
 safety. 
 12.  Boston  Scientific  has  not  provided  sufficient  justification  for  the  extensive  non-  compliance  period  it  requests,  which  easily  could  stretch  to  eight  to  ten  years.  General  references  are  made  to  the 

 time  required  for  careful  design  and  for  obtaining  FDA  regulatory  approval,  affecting  the  time  window  during  which  the  next  generation  devices  could  be  sold,  as  well  as  to  the  millions  of  dollars  claimed  to 
 have  been  spent  on  development  of  those  devices.  We  do  not  disregard  these  assertions.  However,  we  note  that  such  business  concerns,  while  understandably  of  import  to  an  individual  manufacturer  such  as 
 Boston  Scientific,  do  not  address  the  more  pertinent  issue  of  whether  this  particular  rule  waiver  would  serve  the  greater  public  interest.  We  do  not  find  it  apparent  that  the  extensive  period  of  time  requested 
 by  Boston  Scientific  should  be  necessary  to  design  and  receive  approval  for  devices  that  are  fully  compliant  with  our  rules.  Moreover,  it  is  not  apparent  that  the  market  could  not  adjust  to  accommodate 
 Boston  Scientifics  patients,  if  necessary,  over  a  shorter  period  of  time  than  the  eight  to  ten  years  requested. 

 13.  Accordingly,  we  will  permit  Boston  Scientific  a  maximum  of  three  years  to  continue  to  manufacture  and  sell  any  of  the  noncompliant  devices  described  in  its  waiver  petition.  16  More 
 specifically,  we  will  permit  Boston  Scientific  to  continue  to  manufacture  and  sell  its  current  PDM  and  PD2  devices  for  a  period  of  two  years  or  until  six  months  after  final  regulatory  approval  of  their 
 respective  new  replacement  devices,  which  ever  comes  first  in  each  case.  We  will  also  permit  Boston  Scientific  to  continue  to  manufacture  and  sell  its  current  Contak  Renewal  TR  devices  for  a  period  of 
 three  years  or  until  six  months  after  final  regulatory  approval  of  its  new  replacement  device,  which  ever  comes  first.  Finally,  we  will  permit  Boston  Scientific  to  manufacture  and  sell  its  next  generation  devices 
 (after  they  receive  regulatory  approval)  until  three  years  from  the  date  of  this  Order.  We  believe  that  these  time  periods  strike  an  appropriate  balance  between  providing  some  degree  of  relief  to  the  parties 
 under  the  special  circumstances  presented  while  reasonably  minimizing  the  amount  of  time  during  which  non-  compliant  devices  operate  in  the  band,  and  thus  best  serve  the  public  interest  in  this  case. 

 V.  ORDERING  CLAUSE 
 14.  Accordingly,  pursuant  to  Sections  4(  i),  302,  303(  e),  and  303(  r)  of  the  Communications  Act  of  1934,  as  amended  (47  U.  S.  C.    154(  i),  302,  303(  e),  and  303(  r))  and  Section  1.3  of  the  Commissions 

 rules  (47  C.  F.  R.    1.3),  and  under  the  authority  delegated  in  sections  0.31  and  0.241  of  the  Commission's  rules  (47  C.  F.  R.    0.31,  0.241),  IT  IS  ORDERED  that  the  following  waivers  are  granted: 

 15  See  para.  6,  supra. 
 16  Devices  that  are  implanted  in  patients  under  the  provisions  of  these  rules  will  be  permitted  to  continue  to  operate 
 indefinitely. 
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 1)  Respironics,  Inc.  is  permitted  to  manufacture  and  sell  for  a  period  of  12  months  from  the  release  of  this  Order  a  maximum  number  of  1000  uncertified  ActiReader  units  as  described  in  this 
 Order  and  in  its  petition  for  waiver. 
 2)  Boston  Scientific  Corporation  is  permitted  to  manufacture  and  sell  its  uncertified  devices  as  described  in  this  Order  and  in  its  petition  for  waiver  as  follows: 

 a)  PDM  and  PD2  devices  for  two  years  after  release  of  this  Order,  or  until  six  months  after  final  regulatory  approval  of  their  next  generation  replacement  devices,  whichever  comes  first 
 b)  Contak  Renewal  TR  devices  for  three  years  after  release  of  this  Order  or  until  six  months  after  final  regulatory  approval  of  their  next  generation  replacement  devices,  whichever  comes 
 first; 
 c)  Cognis,  Teligen,  and  Ingenio  devices  for  three  years  after  the  release  date  of  this  Order. 

 FEDERAL  COMMUNICATIONS  COMMISSION 

 Julius  P.  Knapp,  Chief  Office  of  Engineering  and  Technology 
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