fda regulations and medical device pathways to market

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Confiden’al FDA Regula+ons and Medical Device Pathways to Market Russ King President (919) 3133962 [email protected] The contents of this presentation is not intended as and should not be interpreted as regulatory advice for any specific product or company.

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Confiden'al  

FDA  Regula+ons  and  Medical  Device  Pathways  to  Market    

Russ  King  President  (919)  313-­‐3962  [email protected]    

The contents of this presentation is not intended as and should not be interpreted as regulatory advice for any specific product or company.

Confiden'al  Medical  Devices  and  the  FDA  

What  is  a  Medical  Device?  

We  know  a  medical  device  when  we  see  it!                  Legal  Defini'on:    An  instrument,  apparatus,  implant,  in  vitro  reagent,  or  similar  or  related  ar'cle  that  is  used  to  diagnose,  prevent,  or  treat  disease  or  other  condi'ons,  and  it  is  not  a  drug.  

     

 

Confiden'al  Medical  Devices  and  the  FDA  

FDA  as  Regulators  of  Medical  Devices  

What  is  the  Food  and  Drug  Administra+on  •  Regulatory  Body  i.e.  a  law  enforcement  agency  •  FDA  enforces  administra've  laws  designed  to  ensure  product    

efficacy  and  public  safety.    Examples  of  FDA  regula'ons:  •  FDA  Product  Approval  Processes  (e.g.  510(k)  approval)  •  21  CFR  Part  820  or  Good  Manufacturing  Prac'ces  (GMPs)  •  21  CFR  Part  11  for  cri'cal  SoYware    

•  Other  Administra've  Laws  you  have  heard  of:  •  Tax  Law  •  Immigra'on  Law  •  Trade  Law  

•  As  a  law  enforcement  agency,  the  FDA  approves  for  the  US  Market  products  subject  to  FDA  over  site  and  when  applicable  laws  are  violated  the  FDA  can  cite,  fine  and  prosecute  for  viola'ons  of  laws  

Confiden'al  Medical  Devices  and  the  FDA  

FDA  as  Regulators  of  Medical  Devices  

 The  Center  for  Devices  and  Radiological  Health  (CDRH)  is  the  branch  of  the  FDA  responsible  for  regula+ng  medical  devices  

Confiden'al  Medical  Devices  and  the  FDA  

FDA  as  regulators  of  Medical  Devices  

Summary  of  FDA  Approval  • FDA  risk  based  approval  process:    

•  Class  I:    FDA  Product  Registra'on  •  Class  II:  Pre-­‐Market  No'fica'on  –  510(k)  •  Class  III:  Pre-­‐Market  Approval  –  PMA  

• Product  approval  requires  a  compliant  Quality  Management  System  (QMS)  

•  General  Controls  •  General  Controls  &  Special  Controls  

Class  IIClass  I Class  III

Implement  Quality  Management  System  that  meets  FDA  Quality  System  Regulation  (QSR)  as  found  in  21  CFR  820

Device  may  require  clinical  data

Develop  clinical  trial  protocol  and  obtain  FDA  approval  to  conduct  trial

FDA  conducts  facility  inspections

Prepare  and  submit  510(k)  application.    Pay  510(k)  Fee

Prepare  and  submit  PMA  for  

completeness  review.

Notified  Body  and/or  FDA  Reviews  

510(k)

Prepare  and  submit  PMA  for  

completeness  review.

FDA  issues  510(k)  clearance  letter

FDA  issues  PMA  approval  letter

Execute  Commercialization  Plan

Confiden'al  Medical  Devices  and  the  FDA  

Product  Component  of  FDA  Approval  

The  FDA  Approval  Path  for  Medical  Devices  Includes  a  Product  Component  and  a  Company  Component    • Product  Component    

•  FDA  uses  a  risk  based  classifica'on  product  approval  process:    The  higher  the  risk,  the  higher  the  eviden'ary  threshold  for  demonstra'ng  product  Safety  and  Efficacy  

•  Low  Risk    -­‐-­‐    Class  I:    FDA  Product  Registra'on  •  Tongue  depressors,  arm  slings,  and  stethoscopes  

•  Medium  Risk  -­‐-­‐  Class  II:  Pre-­‐Market  No'fica'on  –  510(k)  •  physiologic  monitors,  x-­‐ray  systems,  gas  analyzers,  and  pumps  

•  High  Risk  -­‐-­‐  Class  III:  Pre-­‐Market  Approval  –  PMA  •  pacemakers,  replacement  heart  valves  and  total  joint  

replacements  

Confiden'al  Medical  Devices  and  the  FDA  

Product  Component  of  FDA  Approval  

Taking  a  Closer  Look  at  the  510(k)  Process  •  Theore+cal  Founda+on:  Instead  of  proving  your  device  is  safe  and  

effec've  with  clinical  trials  you  can  take  a  shorter  path  for  product  approval  by  demonstra'ng  your  device  is  just  as  safe  and  effec've  as  an  already  approved  device  (i.e.  a  predicate  device)  by  showing  it  is  substan'ally  equivalent  to  a  predicate  device  which  has  already  been  shown  to  be  safe  and  effec've      

•  The  510(k)  process  is  one  which  demonstrates  the  substan'al  equivalence  of  an  unapproved  device  to  an  already  approved  or  predicate  device  

 

Confiden'al  Medical  Devices  and  the  FDA  

Product  Component  of  FDA  Approval  

Establishing  Substan+al  Equivalence  •  Iden'fy  similar  device(s)  that  could  serve  as  a  predicate  •  A  device  is  substan'ally  equivalent  if,  in  comparison  to  a  

predicate  it  has:  •  The  same  intended  use  as  the  predicate;  and  •  The  same  technological  characteris'cs  as  the  predicate;  

Or  •  The  same  intended  use  as  the  predicate;  and  •  Has  different  technological  characteris'cs  and  the  informa'on  

submihed  to  FDA  •  Does  not  raise  new  ques'ons  of  safety  and  effec'veness;  

and  •  Demonstrates  that  the  device  is  at  least  as  safe  and  as  

effec've  as  the  legally  marketed  device  

 

Confiden'al  Medical  Devices  and  the  FDA  

Product  Component  of  FDA  Approval  

De  Novo:    An  Alterna+ve  510(k)  Process  •  Theore+cal  Founda+on:  If  your  medical  device  has  no  substanailly  

equivalent  predicate  device  but  you  can  clearly  demonstrate  that  the  risks  posed  by  the  device  when  used  as  intended  does  not  rise  above  a  moderate  level  of  risk  (i.e.  show  that  the  device  is  appropriately  considered  a  Class  I  or  Class  II  device),  then  the  FDA  may  grant  permission  to  file  a  de  novo  applica'on  

•  The  de  novo  process  is  one  which  demonstrates  the  risk  of  the  device  when  used  as  intended  meets  the  risk  posed  by  either  a  Class  I  or  II  device.    The  de  novo  process  requires  pre-­‐submission  mee'ng(s)  with  and  permission  from  the  FDA.  Though  de  novo  may  represent  a  less  expensive  route  to  market  than  a  PMA  because  it  will  not  require  clinical  trials,  it  may  require  clinical  and  or  performance  data  and  the  de  novo  process  can  add  6  to  18  months  to  the  normal  510(k)  clearance  process  

 

Confiden'al  Medical  Devices  and  the  FDA  

Company  Component  for  FDA  Approval  

The  FDA  Approval  Path  for  Medical  Devices  Includes  a  Product  Component  and  a  Company  Component    Company  Component    

•  FDA  requires    all  Medical  Device  companies  to    have  a  Quality  Management  System  (QMS)  that  complies  with  Good  Manufacturing  Prac'ces    (GMPs;  21  CFR  Part  820)  

•  Low  Risk    -­‐-­‐    Class  I:    QMS  with  General  Controls  •  Medium  Risk  -­‐-­‐    Class  II:  QMS  with  General  Controls  &  Special  Controls  •  High  Risk  -­‐-­‐    Class  III:    QMS  with  General  Controls  and  PMA    

Medical  Devices  and  the  FDA  

General  Controls   General  Controls  &  Special  Controls  Document  Control Document  Control Labeling  /  Packaging  Control Labeling  /  Packaging  Control Record  Control Record  Control Recall  Management Recall  Management Adverse  Event  /  MDR  Repor'ng Adverse  Event  /  MDR  Repor'ng Iden'fica'on  /Traceability  /  Distribu'on

Iden'fica'on  /Traceability  /  Distribu'on

Advisory  No'ces Advisory  No'ces Returned  Products Returned  Products Installa'on Installa'on

    Design  Controls     Risk  Management     SoYware  Valida'on     Post  Market  Surveillance

Confiden'al  

Company  Component  for  FDA  Approval  

21  CFR  Part  820:  General  vs.  Special  Controls  

Medical  Devices  and  the  FDA  

Confiden'al  

Company  Component  for  FDA  Approval  

A  closer  look  at  Design  Controls  •  Establishing  intended  use  and  design  inputs  •  A  design  plan  •  Periodic  design  reviews  throughout  the  design  process  •  Confirma'on  that  the  design  outputs  conform  to  the  design  inputs  

through  design  verifica'on  ("Are  we  making  the  device  according  to  the  design?")  

•  Design  valida'on  (“Are  we  making  the  right  device?")  •  Transla'on  of  the  design  into  manufacturable  specifica'ons  •  Clear  documenta'on  of  the  en're  process  in  a  design  history  file  or  

DHF      

Confiden'al  Medical  Devices  and  the  FDA  

Important  Considera+ons!  

Do  you  need:  •  IEC  60601-­‐1  3rd  Edi'on  Amendment  1  

Safety  Tes'ng?  •  IEC  62304  SDLC  Documenta'on?  •  Clinical  Data?  •  Clinical  Trial?  •  Performance  Data?  •  SoYware  Valida'on  per  21  CFR  Part  11?    

 

Class  IIClass  I Class  III

Implement  Quality  Management  System  that  meets  FDA  Quality  System  Regulation  (QSR)  as  found  in  21  CFR  820

Device  may  require  clinical  data

Develop  clinical  trial  protocol  and  obtain  FDA  approval  to  conduct  trial

FDA  conducts  facility  inspections

Prepare  and  submit  510(k)  application.    Pay  510(k)  Fee

Prepare  and  submit  PMA  for  

completeness  review.

Notified  Body  and/or  FDA  Reviews  

510(k)

Prepare  and  submit  PMA  for  

completeness  review.

FDA  issues  510(k)  clearance  letter

FDA  issues  PMA  approval  letter

Execute  Commercialization  Plan

Confiden'al  Q&A  

Q&A  

Discussion  /  Q&A  

Confiden'al  

Thank  you.  

Russ  King  President  (919)  313-­‐3962  [email protected]