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The  Complete  Guide  to  
FDA  Design  Controls
Part  1  &  2
April  26th,  2016
About  the  Presenter
David  Amor  is  the  co-­‐founder  and  CEO  
of  Medgineering  &  QuickConsult.
• Adjunct  Professor,  St.  Cloud  State  
University  (SCSU)  – MTQ628  
Design  Controls
• 9+  years  of  QA/RA  consulting  
including  DHF  /  risk  mgmt
remediation  projects
• FDA  &  EU  expert  in  QMS
@medgineering
david@medgineering.com
786.546.1806
Medgineering  is  a  medtech consulting  firm  
based  in  Minneapolis,  MN  focusing  on  
regulatory  submissions  and  quality  systems.
www.medgineering.com
www.21cfr820.com
Online  medtech consulting  marketplace  – on  
demand  experts  for  Q&A  and  projects!
www.myquickconsult.com
About  the  Presenter
Jon  Speer  is  the  Founder  &  VP  QA/RA  
of  greenlight.guru.
• 17+  years  in  medical  device  industry
• Product  development  engineer,  
quality  manager,  regulatory  
specialist
• 40+  products  to  market
• Expert  at  QMS  implementations
• Dozens  of  ISO  audits  &  FDA  
inspections
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
+1  317  960  4280
greenlight.guru   produces  beautifully  simple  
quality,  design  control  and  risk  management  
software  exclusively  for  medical  device  
manufacturers.  We  help  you  bring  higher  
quality  devices  to  market  faster  and  with  less  
risk.
http://greenlight.guru
In	
  Part	
  1,	
  you'll	
  learn	
  about	
  Intended	
  Use,	
  User	
  Needs,	
  Design	
  
Inputs,	
  Design	
  Reviews,	
  Design	
  History	
  File	
  (DHF)	
  and	
  Risk	
  
Management.
Specifically:
• The	
  importance	
  of	
  getting	
  your	
  intended	
  use	
  right	
  up	
  front
• The	
  difference	
  between	
  a	
  user	
  need	
  and	
  a	
  design	
  input	
  
that's	
  verifiable
• What	
  stakeholders	
  need	
  to	
  be	
  involved	
  in	
  the	
  process	
  and	
  
why
• When	
  and	
  how	
  many	
  design	
  reviews	
  you	
  should	
  hold
• Why	
  FMEA	
  alone	
  is	
  NOT	
  risk	
  management	
  and	
  how	
  to	
  
integrate	
  risk	
  into	
  the	
  design	
  and	
  development	
  process
In	
  Part	
  2,	
  you'll	
  learn	
  about	
  Design	
  Outputs,	
  Device	
  Master	
  
Record	
  (DMR),	
  Design	
  Verification	
  and	
  Validation	
  (V&V),	
  
Design	
  Transfer	
  and	
  Regulatory	
  Submissions.
Specifically:
• Why	
  your	
  design	
  outputs	
  need	
  to	
  be	
  more	
  than	
  a	
  drawing	
  
and	
  their	
  relationship	
  to	
  your	
  DMR
• How	
  usability	
  and	
  human	
  factors	
  fits	
  into	
  the	
  overall	
  product	
  
development
• Making	
  sure	
  you	
  build	
  the	
  correct	
  device	
  and	
  build	
  it	
  
correctly	
  with	
  design	
  V&V
• Common	
  mistakes	
  people	
  make	
  during	
  design	
  transfer	
  to	
  
production	
  and	
  how	
  to	
  avoid	
  them
• When	
  you	
  can	
  and	
  should	
  make	
  your	
  regulatory	
  submission
Design  Controls
An  introduction
1997.
21  CFR  820.30.
FDA Design Controls: What Medical Device Makers Need to Know
Design  Controls  – when?
Any	
  Class	
  II	
  or	
  Class	
  III	
  medical	
  device	
  developed	
  in	
  the	
  
US	
  – part	
  of	
  quality	
  system	
  (QMS).
Investigational	
  Device	
  Exemption	
  (IDE)	
  – 21	
  CFR	
  812.
FDA Design Controls: What Medical Device Makers Need to Know
FDA Design Controls: What Medical Device Makers Need to Know
FDA Design Controls: What Medical Device Makers Need to Know
User  Needs  &  Design  Input
The  FDA  differentiates  between
user  needs  and  technical  requirements
Regulation Description
21CFR	
  820 Quality	
  System	
  Regulation
Subpart C Design	
  Controls
Use	
  a	
  development	
  plan.	
  Keep	
  it	
  short	
  and	
  
sweet.	
  Don’t	
  overcommit	
  and	
  don’t	
  make	
  it	
  too	
  
prescriptive.
820.30	
  Design	
  Controls Design	
  Planning
820.30	
  Design	
  Controls Design	
  Planning
The	
  extent	
  of	
  design	
  and	
  
development	
  planning	
  should	
  
reflect	
  company	
  size	
  and	
  
complexity	
  and	
  any	
  outsourcing.
• Refining	
  is	
  OK	
  – especially	
  for	
  new	
  
portfolio	
  products
• Identify	
  key	
  milestones	
  and	
  dates	
  only
• Detail	
  should	
  be	
  dependent	
  on	
  risk
• If	
  outsourcing	
  development	
  work,	
  
identify	
  the	
  resources	
  and	
  integration
820.30	
  Design	
  Controls Design	
  Planning
“You	
  state	
  in	
  your	
  response	
  that	
  you	
  plan	
  on	
  making	
  your	
  
design	
  plan	
  more	
  robust.	
  We	
  would	
  like	
  to	
  clarify	
  that	
  this	
  
plan,	
  as	
  per	
  21	
  CFR	
  820.30(b),	
  “shall	
  identify	
  and	
  describe	
  the	
  
interface	
  between	
  groups	
  that	
  provide,	
  or	
  result	
  in,	
  input	
  to	
  
the	
  design	
  development	
  process.	
  The	
  plans	
  shall	
  be	
  
reviewed,	
  updated,	
  and	
  approved	
  as	
  design	
  and	
  
development	
  evolves.”	
  The	
  design	
  plan	
  for	
  Avex	
  CX2	
  and	
  
CXi2,	
  reviewed	
  during	
  the	
  current	
  inspection,	
  was	
  observed	
  
to	
  lack	
  this	
  data	
  including,	
  but	
  not	
  limited	
  to,	
  completed	
  and	
  
approved	
  plans	
  for:	
  Development,	
  Clinical,	
  Risk	
  Management,	
  
Quality	
  Processing,	
  Manufacturing,	
  and	
  Manufacturing	
  
Qualification”
Discussion	
   Point:	
  Lack	
  of	
  documented	
  planning	
  shows	
  poor	
  oversight	
  
of	
  your	
  processes.	
  Development	
  planning	
  may	
  change	
  with	
  new	
  
information	
  – up	
  to	
  the	
  point	
  of	
  design	
  freeze.
Regulation Description
21CFR	
  820 Quality	
  System	
  Regulation
Subpart C Design	
  Controls
Design	
  inputs	
  need	
  to	
  be	
  organized	
  and	
  
differentiated	
  between	
  users,	
  customers	
  and	
  
stakeholders.	
  Design	
  inputs	
  must	
  be	
  clear	
  and	
  
verifiable.
820.30	
  Design	
  Controls Design	
  Inputs
820.30	
  Design	
  Controls Design	
  Inputs
Design	
  requirements	
  are	
  the	
  single	
  
most	
  important	
  factor	
  in	
  820.30
“There’s	
  never	
  time	
  to	
  do	
  it	
  right	
  but	
  
there’s	
  always	
  time	
  to	
  do	
  it	
  over!”
• Comprehensive	
  – per	
  risk
• Methodical
• Linked	
  to	
  clinical	
  or	
  other	
  rationale
820.30	
  Design	
  Controls Design	
  Inputs
“Drilling	
  down”	
  inputs	
  is	
  critical.
• Refining	
  is	
  OK	
  – especially	
  for	
  new	
  
portfolio	
  products
• Identify	
  key	
  milestones	
  and	
  dates	
  only
• Detail	
  should	
  be	
  dependent	
  on	
  risk
• If	
  outsourcing	
  development	
  work,	
  
identify	
  the	
  resources	
  and	
  integration
820.30	
  Design	
  Controls Design	
  Inputs
“Drilling	
  down”	
  inputs	
  is	
  critical.
User	
  Needs
Marketing	
  
Needs
Customer	
  
Needs
Other	
  
Stakeholder	
  
Needs
“Concept”	
  Documents	
  per	
  FDA	
  
Guidance	
  1997	
  Design	
  Controls
820.30	
  Design	
  Controls Design	
  Inputs
Am	
  I	
  ever	
  going	
  to	
  tell	
  you	
  
that	
  I	
  need	
  a	
  catheter	
  
with	
  a	
  tensile	
  strength	
  of	
  
10	
  +/-­‐ 2	
  N?
“Drilling	
  down”	
  inputs	
  is	
  critical.
User	
  Needs
Marketing	
  
Needs
Customer	
  
Needs
Other	
  
Stakeholder	
  
Needs
820.30	
  Design	
  Controls Design	
  Inputs
Product	
  
Requirements
• Solution	
  independent
• Clear
• Concise
• Verifiable
“Drilling	
  down”	
  inputs	
  is	
  critical.
User	
  Needs
Marketing	
  
Needs
Customer	
  
Needs
Other	
  
Stakeholder	
  
Needs
820.30	
  Design	
  Controls Design	
  Inputs
“Drilling	
  down”	
  inputs	
  is	
  critical.
User	
  Needs
Marketing	
  
Needs
Customer	
  
Needs
Other	
  
Stakeholder	
  
Needs
Product	
  
Requirements
Specifications
WHAT? HOW!
820.30	
  Design	
  Controls Design	
  Inputs
The	
  catheter	
  shall	
  
be	
  easy	
  to	
  
manipulate.
The	
  catheter	
  shall	
  
have	
  a	
  torque	
  ratio	
  
of	
  1:1	
  
User	
  Need
(Requirement)
Design	
  Input
(Requirement)
Design	
  Output
(Specification)
Material	
  specifications
Test	
  methods
Drawings
820.30	
  Design	
  Controls Design	
  Inputs
Design	
  Input
(Requirement)
The	
  catheter	
  shall	
  
have	
  a	
  torque	
  ratio	
  
of	
  1:1	
  
This	
  may	
  involve	
  iterative	
  
testing	
  until	
  the	
  design	
  input	
  
requirement	
  is	
  determined.
• TBD	
  in	
  initial	
  drafts	
  of	
  DI	
  
documents	
  are	
  acceptable	
  –
help	
  guide	
  feasibility	
  testing!
• May	
  shift	
  over	
  time
• Impact	
  assessment
820.30	
  Design	
  Controls Design	
  Inputs
“Failure	
  to	
  establish	
  and	
  maintain	
  
adequate	
  procedures	
  to	
  ensure	
  that	
  the	
  
design	
  requirements	
  relating	
  to	
  a	
  device	
  
are	
  appropriate	
  and	
  address	
  the	
  intended	
  
use	
  of	
  the	
  device,	
  including	
  the	
  needs	
  of	
  
the	
  user	
  and	
  patient,	
  as	
  required	
  by	
  21	
  CFR	
  
820.30(c)”
Discussion	
  Point:	
  When	
  you	
  create	
  a	
  user	
  needs	
  /	
  requirement	
  
document,	
  are	
  you	
  linking	
  it	
  back	
  to	
  the	
  intended	
  use	
  of	
  the	
  
device?	
  
820.30	
  Design	
  Controls Design	
  Inputs
Design	
  Inputs	
  must	
  be	
  clear	
  
(unambiguous)	
  and	
  verifiable.
• If	
  basing	
  design	
  inputs	
  on	
  a	
  standard,	
  
make	
  sure	
  the	
  standard	
  reference	
  is	
  
specific,	
  clear,	
  and	
  test-­‐able
• When	
  you	
  think	
  of	
  design	
  inputs,	
  think	
  
“engineering”	
  and	
  “getting	
  technical”
• Find	
  a	
  resource	
  for	
  writing	
  requirements
820.30	
  Design	
  Controls Design	
  Inputs
Design	
  Inputs	
  must	
  be	
  clear	
  
(unambiguous)	
  and	
  verifiable.
“Device	
  shall	
  be	
  portable”….
820.30	
  Design	
  Controls Design	
  Inputs
Design	
  Inputs	
  must	
  be	
  clear	
  
(unambiguous)	
  and	
  verifiable.
“Device	
  shall	
  be	
  compliant	
  to	
  ISO	
  10993-­‐1…”
820.30	
  Design	
  Controls Design	
  Inputs
Design	
  Inputs	
  must	
  be	
  clear	
  
(unambiguous)	
  and	
  verifiable.
Device	
  shall	
  be	
  flexible
Device	
  shall	
  be	
  formed	
  into	
  a	
  50	
  mm	
  
diameter	
  coil	
  and	
  straightened	
  out	
  for	
  
a	
  total	
  of	
  50	
  times	
  with	
  no	
  evidence	
  of	
  
cracking	
  or	
  deformity.
NOTE: assess	
  the	
  level	
  of	
  granularity	
  or	
  detail	
  based	
  on	
  requirement	
  
criticality/	
  risk.
VS
820.30	
  Design	
  Controls Design	
  Inputs
F	
  P	
  I	
  S.
• Functional:	
  what	
  does	
  the	
  device	
  do?
• Performance:	
  accuracy,	
  conditions,	
  
operational	
  limits,	
  reliability,	
  etc.
• Interface:	
  what	
  does	
  the	
  device	
  need	
  to	
  have	
  
to	
  work	
  with	
  accessories	
  or	
  external	
  items?
• Safety:	
  does	
  the	
  device	
  need	
  precautionary	
  
measures	
  or	
  safety	
  margins?
A	
  note	
  on	
  drafting	
  requirements.
• Language	
  is	
  important
a) ‘Shall’	
  vs.	
  ‘Should’
a) “Must	
  have”	
  vs.	
  “Nice	
  to	
  have”
b) Avoid	
  “as	
  applicable”	
  or	
  “as	
  required”	
  in	
  final	
  DI	
  
• Avoid	
  contradicting	
  requirements
• System	
  à sub-­‐system
a) Particularly	
  useful	
  for	
  contracting
820.30	
  Design	
  Controls Design	
  Inputs
A	
  note	
  on	
  drafting	
  requirements.
• Avoid	
  comparative	
  requirements
• Ex:	
  “…shall	
  be	
  20%	
  better	
  than	
  the	
  predicate.”
• Avoid	
  multiple	
  objectives	
  in	
  same	
  requirement
• Avoid	
  “NOTEs”!!!
• INCOSE	
  “Writing	
  technical	
  requirements”
820.30	
  Design	
  Controls Design	
  Inputs
820.30	
  Design	
  Controls Design	
  Inputs
Don’t	
  stress	
  about	
  documenting	
  
design	
  inputs	
  in	
  proof	
  of	
  concept	
  or	
  
feasibility	
  phases.	
  Be	
  agile!
• FDA	
  distinguishes	
  between	
  R&D	
  and	
  
finished	
  product	
  – remember	
  this!	
  
• Design	
  inputs	
  apply	
  to	
  the	
  
commercial	
  product	
  (“how	
  do	
  I	
  know	
  
the	
  design	
  is	
  in	
  control?”)
The  importance  of  traceability.
“Failure	
  to	
  establish	
  and	
  maintain	
  
adequate	
  procedures	
  for	
  verifying	
  the	
  
device	
  design,	
  as	
  required	
  by	
  21	
  CFR	
  
820.30(f).	
  Specifically,	
  design	
  outputs	
  were	
  
not	
  always	
  evaluated	
  to	
  demonstrate	
  that	
  
the	
  outputs	
  met	
  design	
  inputs.”
FDA Design Controls: What Medical Device Makers Need to Know
Risk  Management
An  overview
Risk	
  Management Design	
  Controls
Intended	
  Use	
  is	
  important	
  for	
  
Design	
  Controls	
  &	
  Risk	
  
Management.
Risk	
  Management	
  &	
  Design	
  Controls	
  
are	
  about	
  demonstrating	
  a	
  medical	
  
device	
  is	
  SAFE	
  and	
  EFFECTIVE.
Risk	
  Management Design	
  Controls
Product	
  Risk	
  Management	
  is	
  a	
  
cycle,	
  even	
  during	
  product	
  
development.
• Start	
  Risk	
  Management	
  process	
  early
• Use	
  Risk	
  Management	
  process	
  to	
  
improve	
  product	
  design
• Use	
  Design	
  Controls	
  to	
  support	
  Risk	
  
Controls	
  /	
  Mitigations
FDA Design Controls: What Medical Device Makers Need to Know
RISK	
  MANAGEMENT-­‐ systematic	
  application	
  of	
  management	
  
policies,	
  procedures,	
  and	
  practices	
  to	
  the	
  tasks	
  of	
  analyzing,	
  
evaluating,	
  controlling,	
  and	
  monitoring	
  risk
RISK -­‐ combination	
  of	
  the	
  probability	
  of	
  occurrence	
  of	
  harm	
  
and	
  the	
  severity	
  of	
  that	
  harm
ISO	
  14971	
  Risk	
  Management Key	
  Terms
HAZARD -­‐ potential	
  source	
  of	
  harm
HAZARDOUS	
  SITUATION -­‐ circumstance	
  in	
  which	
  people,	
  
property,	
  or	
  the	
  environment	
  are	
  exposed	
  to	
  one	
  or	
  more	
  
hazard(s)
HARM -­‐ physical	
  injury	
  or	
  damage	
  to	
  the	
  health	
  of	
  people,	
  or	
  
damage	
  to	
  property	
  or	
  the	
  environment
SEVERITY -­‐ measure	
  of	
  the	
  possible	
  consequences	
  of	
  a	
  hazard
ISO	
  14971	
  Risk	
  Management Key	
  Terms
RISK	
  ANALYSIS -­‐ systematic	
  use	
  of	
  available	
  information	
  to	
  
identify	
  hazards	
  and	
  to	
  estimate	
  the	
  risk
RISK	
  ESTIMATION -­‐ process	
  used	
  to	
  assign	
  values	
  to	
  the	
  
probability	
  of	
  occurrence	
  of	
  harm	
  and	
  the	
  severity	
  of	
  that	
  harm
RISK	
  EVALUATION -­‐ process	
  of	
  comparing	
  the	
  estimated	
  risk	
  
against	
  given	
  risk	
  criteria	
  to	
  determine	
  the	
  acceptability	
  of	
  the	
  
risk
RISK	
  ASSESSMENT -­‐ overall	
  process	
  comprising	
  a	
  risk	
  analysis	
  
and	
  a	
  risk	
  evaluation
RISK	
  CONTROL -­‐ process	
  in	
  which	
  decisions	
  are	
  made	
  and	
  
measures	
  implemented	
  by	
  which	
  risks	
  are	
  reduced	
  to,	
  or	
  
maintained	
  within,	
  specified	
  levels
RESIDUAL	
  RISK -­‐ risk	
  remaining	
  after	
  risk	
  control	
  measures	
  
have	
  been	
  taken
ISO	
  14971	
  Risk	
  Management Key	
  Terms
ISO	
  14971	
  Risk	
  Management Process	
  Overview
ISO	
  14971	
  Risk	
  Management Establish	
  Framework
ISO	
  14971	
  Risk	
  Management Risk	
  Analysis
ISO	
  14971	
  Risk	
  Management Risk	
  Analysis
I	
  can	
  be	
  a	
  valuable	
  
resource	
  throughout	
  the	
  
Risk	
  Management	
  
Process!
Include	
  end-­‐users	
  as	
  part	
  of	
  the	
  
process.
Hazards
Foreseeable	
  
Sequence	
  of	
  
Events
Hazardous	
  
Situations
Harms
ISO	
  14971	
  Risk	
  Management Risk	
  Evaluation
ISO	
  14971	
  Risk	
  Management Risk	
  Evaluation
Risk	
  Evaluation	
  criteria	
  shall	
  be	
  
established	
  and	
  should	
  be	
  specific	
  
to	
  your	
  product.	
  
• Use	
  sources	
  like	
  MAUDE	
  and	
  other	
  
industry	
  databases.
• Consult	
  with	
  end-­‐users	
  to	
  understand	
  
true	
  severity.
• Evaluate	
  other	
  similar	
  products.
• Leverage	
  standards	
  and	
  guidance	
  
documents.
ISO	
  14971	
  Risk	
  Management Risk	
  Assessment
ISO	
  14971	
  Risk	
  Management Risk	
  Assessment
ISO	
  14971	
  Risk	
  Management Risk	
  Control
ISO	
  14971	
  Risk	
  Management Risk	
  Control
Risk	
  Controls	
  are	
  means	
  to	
  
demonstrate	
  risks	
  have	
  been	
  
reduced	
  to	
  acceptable	
  levels.	
  
Priority	
  of	
  Risk	
  Control	
  options:
1. Inherent	
  safety	
  by	
  design
2. Protective	
  measures	
  in	
  the	
  medical	
  
device	
  itself	
  or	
  in	
  the	
  manufacturing	
  
process.
3. Information	
  for	
  safety.
Recommend	
  identifying	
  Risk	
  Controls	
  for	
  
ALL risks.
ISO	
  14971	
  Risk	
  Management Risk	
  Control
My	
  Design	
  Outputs,	
  
Design	
  Verifications,	
  
and	
  Design	
  Validations	
  
can	
  be	
  used	
  as	
  Risk	
  
Control	
  Measures.
FDA Design Controls: What Medical Device Makers Need to Know
ISO	
  14971	
  Risk	
  Management Risk	
  Acceptability
ISO	
  14971	
  Risk	
  Management Risk	
  Acceptability
Have	
  me	
  help	
  you	
  
with	
  risk	
  /	
  benefit	
  
analysis	
  of	
  your	
  
product.
Medical	
  benefits	
  of	
  the	
  medical	
  
device	
  need	
  to	
  outweigh	
  the	
  risks	
  to	
  
patients	
  and	
  end-­‐users.
ISO	
  14971	
  Risk	
  Management Risk	
  Management	
  Report
ISO	
  14971	
  Risk	
  Management Production	
  /	
  Post-­‐Production
Design  Review
An  overview
Regulation Description
21CFR	
  820 Quality	
  System	
  Regulation
Subpart C Design	
  Controls
Design	
  reviews	
  shall	
  be	
  planned	
  and	
  conducted	
  
at	
  appropriate	
  stages	
  during	
  medical	
  device	
  
product	
  development.
820.30	
  Design	
  Controls Design	
  Review
820.30	
  Design	
  Controls Design	
  Review
“Failure	
  to	
  document	
  the	
  design	
  review	
  results,	
  including	
  
the	
  date,	
  in	
  the	
  design	
  history	
  file,	
  as	
  required	
  by	
  21	
  CFR	
  
820.30(e).”
“Design	
  reviews	
  were	
  not	
  performed	
  and/or	
  documented	
  
for	
  the	
  .	
  .	
  .design	
  project	
  as	
  required	
  in	
  the	
  work	
  
instruction	
  or	
  the	
  design	
  plan.”
“Design	
  reviews	
  were	
  conducted;	
  however,	
  the	
  records	
  fail	
  
to	
  indicate	
  the	
  date	
  or	
  dates	
  the	
  design	
  reviews	
  were	
  
conducted	
  and	
  fail	
  to	
  indicate	
  the	
  results	
  of	
  the	
  design	
  
reviews	
  as	
  required	
  in	
  the	
  work	
  instruction.
“However,	
  there	
  were	
  no	
  records	
  of	
  any	
  design	
  reviews	
  
having	
  been	
  conducted	
  after	
  the	
  design	
  changes	
  were	
  
implemented	
  or	
  transferred	
  to	
  production.”
820.30	
  Design	
  Controls Design	
  Review
Timing	
  of	
  design	
  reviews	
  is	
  a	
  
function	
  of	
  design	
  planning.	
  
Frequency	
  of	
  design	
  reviews	
  should	
  
reflect	
  complexity	
  of	
  product	
  
development.
• All	
  design	
  controls	
  need	
  to	
  be	
  part	
  of	
  
design	
  reviews.
• Design	
  plan	
  shall	
  identify	
  when	
  design	
  
reviews	
  are	
  to	
  happen.
• Design	
  reviews	
  shall	
  include	
  an	
  
“independent	
  reviewer”.
• Design	
  reviews	
  shall	
  include	
  appropriate	
  
functions.
FDA Design Controls: What Medical Device Makers Need to Know
Design  History  File
What  goes  in  DHF?
Regulation Description
21CFR	
  820 Quality	
  System	
  Regulation
Subpart C Design	
  Controls
DHF	
  contains	
  documented	
  evidence	
  that	
  
medical	
  device	
  was	
  developed	
  according	
  to	
  
established	
  design	
  plan.
DHF	
  contains	
  all	
  design	
  controls.
820.30	
  Design	
  Controls Design	
  History	
  File	
  (DHF)
820.30	
  Design	
  Controls Design	
  History	
  File	
  (DHF)
“Failure	
  to	
  establish	
  and	
  maintain	
  a	
  design	
  
history	
  file	
  for	
  each	
  type	
  of	
  device,	
  as	
  
required	
  by	
  21	
  CFR	
  820.30(j). For	
  example,	
  
your	
  firm	
  was	
  unable	
  to	
  demonstrate	
  when	
  
key	
  elements	
  of	
  a	
  design	
  history	
  file	
  for	
  the	
  
design	
  project	
  were	
  conducted	
  and	
  
approved,	
  such	
  as	
  design	
  inputs,	
  outputs,	
  
verification,	
  validation,	
  and	
  design	
  
transfer.”
820.30	
  Design	
  Controls Design	
  History	
  File	
  (DHF)
If	
  it	
  isn’t	
  documented,	
  then	
  it	
  didn’t	
  
happen.	
  
Document	
  all	
  Design	
  Controls	
  and	
  
keep	
  records	
  in	
  an	
  organized	
  DHF.
• Establish	
  a	
  DHF	
  per	
  product.
• Use	
  Design	
  Reviews	
  to	
  confirm	
  Design	
  
Controls	
  have	
  been	
  documented.	
  
• Compile	
  DHF	
  into	
  a	
  “single	
  source	
  of	
  
truth”.
820.30	
  Design	
  Controls Design	
  History	
  File	
  (DHF)
It	
  is	
  my	
  responsibility	
  
to	
  document	
  design	
  
controls	
  and	
  maintain	
  
the	
  DHF.
Q&A
Part  1
David  Amor
@medgineering
david@medgineering.com
786.546.1806
www.medgineering.com
www.21cfr820.com
www.myquickconsult.com
Jon  Speer
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
+1  317  960  4280
Quality  Management  Software  
Exclusively  for  Med  Devices
http://greenlight.guru
Getting  in  Touch
The  Complete  Guide  to  
FDA  Design  Controls
Part  2
In	
  Part	
  2,	
  you'll	
  learn	
  about	
  Design	
  Outputs,	
  Device	
  Master	
  
Record	
  (DMR),	
  Design	
  Verification	
  and	
  Validation	
  (V&V),	
  
Design	
  Transfer	
  and	
  Regulatory	
  Submissions.
Specifically:
• Why	
  your	
  design	
  outputs	
  need	
  to	
  be	
  more	
  than	
  a	
  drawing	
  
and	
  their	
  relationship	
  to	
  your	
  DMR
• How	
  usability	
  and	
  human	
  factors	
  fits	
  into	
  the	
  overall	
  product	
  
development
• Making	
  sure	
  you	
  build	
  the	
  correct	
  device	
  and	
  build	
  it	
  
correctly	
  with	
  design	
  V&V
• Common	
  mistakes	
  people	
  make	
  during	
  design	
  transfer	
  to	
  
production	
  and	
  how	
  to	
  avoid	
  them
• When	
  you	
  can	
  and	
  should	
  make	
  your	
  regulatory	
  submission
Design  Outputs  &  DMR
Design  Outputs  – more  than  just  drawings!
Regulation Description
21CFR	
  820 Quality	
  System	
  Regulation
Subpart C Design	
  Controls
Design	
  outputs	
  aren’t just	
  specifications	
  and	
  
drawings.
820.30	
  Design	
  Controls Design	
  Outputs
820.30	
  Design	
  Controls Design	
  Outputs
What	
  can	
  I	
  show	
  you	
  in	
  my	
  books	
  to	
  
demonstrate	
  that	
  the	
  design	
  inputs	
  are	
  being	
  
met/	
  fulfilled/	
  satisfied	
  – how	
  can	
  I	
  prove	
  it?
• “Establish	
  and	
  maintain	
  procedures	
  for	
  
documenting	
  design	
  output	
  in	
  terms	
  that	
  
allow	
  an	
  adequate	
  evaluation	
  of	
  
conformance	
  to	
  design	
  input	
  requirements”
820.30	
  Design	
  Controls Design	
  Outputs
• PLAIN	
  ENGLISH:	
  “We	
  need	
  a	
  documented	
  
way	
  to	
  show	
  how	
  we	
  show	
  that	
  our	
  design	
  
inputs	
  are	
  met	
  – a	
  drawing,	
  a	
  specification,	
  
results	
  of	
  a	
  test,	
  methods,	
  etc.”
• “Design	
  output	
  procedures	
  shall	
  contain	
  or	
  
make	
  reference	
  to	
  acceptance	
  criteria….”
820.30	
  Design	
  Controls Design	
  Outputs
• PLAIN	
  ENGLISH:	
  How	
  do	
  we	
  know	
  a	
  design	
  
input	
  requirement	
  is	
  met?	
  Acceptance	
  
criteria.	
  The	
  output	
  must	
  be	
  clearly	
  marked	
  
to	
  be	
  able	
  to	
  show	
  this!
• “and	
  shall	
  ensure	
  that	
  those	
  design	
  outputs	
  
that	
  are	
  essential	
  for	
  the	
  proper	
  functioning	
  
of	
  the	
  device	
  are	
  identified.”
820.30	
  Design	
  Controls Design	
  Outputs
• PLAIN	
  ENGLISH:	
  ‘Essential	
  for	
  proper	
  
functioning’	
  means	
  you	
  should	
  know	
  the	
  
Intended	
  Use	
  and	
  what	
  design	
  aspects	
  are	
  
most	
  critical	
  to	
  meet	
  it.
820.30	
  Design	
  Controls Design	
  Outputs
Design	
  outputs:	
  format	
  
and	
  type
Drawings
Material	
  
Specification
Inspection	
  
reports.
Service	
  
instructions.
Mfg
Instructions
Batch	
  
Records
Testing	
  
instructions.
Software	
  
code.
QA	
  specs/	
  
procedures.
Packaging/	
  
Labeling.
Risk	
  Mgmt
File
Test	
  results.
820.30	
  Design	
  Controls Design	
  Outputs
“Failure	
  to	
  establish	
  and	
  maintain	
  
adequate	
  procedures	
  for	
  verifying	
  the	
  
device	
  design,	
  as	
  required	
  by	
  21	
  CFR	
  
820.30(f).	
  Specifically,	
  design	
  outputs	
  were	
  
not	
  always	
  evaluated	
  to	
  demonstrate	
  that	
  
the	
  outputs	
  met	
  design	
  inputs.”
Discussion	
  Point:	
   Some	
  companies	
  use	
  DOORS	
  or	
  other	
  similar	
  
requirements	
  traceability	
  programs	
  – what	
  are	
  the	
  pros	
  and	
  
cons	
  with	
  those	
  programs?
820.30	
  Design	
  Controls Design	
  Outputs
”For	
  example,	
  change	
  summary	
  report,	
  
DP#05-­‐11	
  – “ICL	
  Change	
  of	
  Packaging	
  
Solution	
  from	
  (b)(4) to	
  (b)(4)”	
  lacks	
  the	
  
necessary	
  attachments,	
  references	
  and	
  
reports	
  necessary	
  to	
  compare	
  the	
  design	
  
inputs	
  with	
  the	
  design	
  outputs	
  and	
  
determine	
  the	
  adequacy	
  of	
  the	
  
verification.”
Discussion	
  Point:	
   Some	
  companies	
  use	
  DOORS	
  or	
  other	
  similar	
  
requirements	
  traceability	
  programs	
  – what	
  are	
  the	
  pros	
  and	
  
cons	
  with	
  those	
  programs?
The	
  total	
  finished	
  design	
  output	
  consists	
  of	
  the	
  
device,	
  its	
  packaging	
  and	
  labeling,	
  and	
  the	
  
device	
  master	
  record.	
  
820.30	
  Design	
  Controls Design	
  Outputs
The	
  DMR	
  is	
  the	
  “one	
  stop	
  shop”	
  for	
  design	
  
outputs,	
  often	
  maintained	
  in	
  a	
  DMR	
  Index.
Design  Verification  &  
Design  Validation
An  overview
FDA Design Controls: What Medical Device Makers Need to Know
820.30	
  Design	
  Controls Design	
  Verification
Did	
  I	
  design	
  my	
  
medical	
  device	
  
correctly?	
  
Design	
  Input
(Requirement)
Design	
  Output
(Specification)
Design	
  Verification
820.30	
  Design	
  Controls Design	
  Validation
Did	
  you	
  design	
  the	
  
correct	
  medical	
  
device?
User	
  Needs Medical	
  Device Design	
  Validation
FDA Design Controls: What Medical Device Makers Need to Know
820.30	
  Design	
  Controls Design	
  Verification
“Failure	
  to	
  establish	
  and	
  maintain	
  adequate	
  procedures	
  
for	
  verifying	
  the	
  device	
  design. Design	
  verification	
  shall	
  
confirm	
  that	
  the	
  design	
  output	
  meets	
  the	
  design	
  input	
  
requirements,	
  as	
  required	
  by	
  21	
  CFR	
  820.30(f). For	
  
example:
Your	
  firm	
  failed	
  to	
  validate	
  test	
  methods	
  implemented	
  
during	
  design	
  verification	
  testing. These	
  test	
  methods	
  
were	
  created	
  in-­‐house	
  to	
  verify	
  your	
  firm’s	
  design	
  inputs;	
  
however,	
  they	
  were	
  not	
  based	
  on	
  and	
  did	
  not	
  follow	
  a	
  
national	
  standard.
Your	
  firm	
  failed	
  to	
  follow	
  its	
  test	
  procedure	
  during	
  design	
  
verification	
  testing.
Your	
  firm	
  performed	
  design	
  verification	
  prior	
  to	
  
establishing	
  design	
  inputs.”
820.30	
  Design	
  Controls Design	
  Validation
“Your	
  firm	
  failed	
  to	
  establish	
  (i.e.,	
  define,	
  document,	
  and	
  
implement)	
  and	
  maintain	
  design	
  validation	
  procedures	
  to	
  
ensure	
  that	
  devices	
  conform	
  to	
  defined	
  user	
  needs	
  and	
  
intended	
  uses	
  and	
  shall	
  include	
  testing	
  of	
  production	
  units	
  
under	
  actual	
  or	
  simulated	
  use	
  conditions,	
   as	
  required	
  by	
  
21	
  CFR	
  820.30(g).
For	
  example,	
  your	
  firm	
  failed	
  to	
  implement	
  its	
  established	
  
procedure	
  for	
  design	
  validation.	
  .	
  . However,	
  prior	
  to	
  
commercially	
  releasing	
  your	
  product,	
   your	
  firm	
  failed	
  to	
  
conduct	
  design	
  validation	
  of	
  the	
  device	
  constituent	
  part	
  of	
  
this	
  combination	
  product,	
  as	
  required	
  by	
  your	
  SOP. ”
Regulation Description
21CFR	
  820 Quality	
  System	
  Regulation
Subpart C Design	
  Controls
Design	
  Verification	
  demonstrates	
  that	
  the	
  
medical	
  device	
  Design	
  Outputs	
  meet	
  the	
  Design	
  
Inputs.
820.30	
  Design	
  Controls Design	
  Verification
820.30	
  Design	
  Controls Design	
  Verification
Design	
  Verification	
  shall	
  provide	
  
clear,	
  objective	
  evidence	
  that	
  
Design	
  Outputs	
  meet	
  Design	
  Inputs
• Consider	
  Design	
  Verification	
  when	
  
defining	
  Design	
  Inputs
• Establish	
  a	
  Design	
  Verification	
  Plan	
  (and	
  
do	
  so	
  early)
• Define	
  verification	
  methods
• Demonstrate	
  acceptance	
  criteria	
  is	
  met
820.30	
  Design	
  Controls Design	
  Verification
The	
  catheter	
  shall	
  
have	
  a	
  torque	
  ratio	
  
of	
  1:1	
  
Design	
  Input
(Requirement)
Design	
  Output
(Specification)
Material	
  specifications Plans
Drawings
Design	
  Verification
Results
Methods
820.30	
  Design	
  Controls Design	
  Verification
Testing
Inspection
Analysis
Design	
  Verification	
  
Plan
Design	
  Verification	
  Methods
FDA Design Controls: What Medical Device Makers Need to Know
820.30	
  Design	
  Controls Design	
  Verification
• Design	
  Inputs	
  must	
  be	
  clear	
  
(unambiguous)	
  and	
  verifiable.
• Design	
  Outputs	
  must	
  be	
  defined	
  so	
  that	
  
conformance	
  to	
  Design	
  Inputs	
  may	
  be	
  
demonstrated.
• Need	
  to	
  establish	
  “acceptance	
  criteria”.
• Establish	
  (and	
  validate)	
  Design	
  
Verification	
  methods.
820.30	
  Design	
  Controls Design	
  Verification
Testing
Inspection
Analysis
Design	
  Verification	
  
Plan
Results
Design	
  Verification	
  Methods
FDA Design Controls: What Medical Device Makers Need to Know
820.30	
  Design	
  Controls Design	
  Verification
Did	
  I	
  design	
  my	
  
medical	
  device	
  
correctly?	
  
Design	
  Input
(Requirement)
Design	
  Output
(Specification)
Design	
  Verification
Regulation Description
21CFR	
  820 Quality	
  System	
  Regulation
Subpart C Design	
  Controls
Design	
  Validation	
  demonstrates	
  that	
  the	
  
medical	
  device	
  meets	
  the	
  needs	
  of	
  the	
  end-­‐
user(s).
820.30	
  Design	
  Controls Design	
  Validation
820.30	
  Design	
  Controls Design	
  Validation
Design	
  Validation	
  shall	
  provide	
  
clear,	
  objective	
  evidence	
  that	
  the	
  
medical	
  device	
  meets	
  the	
  needs	
  of	
  
the	
  end-­‐users.	
  
• Establish	
  a	
  Design	
  Validation	
  Plan	
  (and	
  
do	
  so	
  early)
• Use	
  regulatory	
  product	
  classification
• Involves	
  “clinical	
  evaluation”	
  in	
  actual	
  or	
  
simulated	
  use	
  with	
  actual	
  end-­‐users
• Product	
  is	
  production	
  equivalent	
  
• Includes	
  the	
  entire	
  product,	
  including	
  
packaging	
  and	
  labeling
820.30	
  Design	
  Controls Design	
  Validation
• “Clinical	
  evaluation”	
  does	
  NOT	
  just	
  
mean	
  actual	
  use.
• Actual	
  use	
  will	
  likely	
  require	
  addressing	
  
additional	
  regulatory	
  criteria.
• For	
  many	
  devices,	
  simulated	
  use	
  is	
  more	
  
than	
  sufficient.
820.30	
  Design	
  Controls Design	
  Validation
User	
  Needs Medical	
  Device
Plans
Design	
  Validation
Results
Methods
The	
  catheter	
  shall	
  
be	
  easy	
  to	
  
manipulate.
820.30	
  Design	
  Controls Design	
  Validation
TESTING!!
Inspection
Analysis
Design	
  Validation	
  
Plan
Design	
  Validation	
  Methods
FDA Design Controls: What Medical Device Makers Need to Know
820.30	
  Design	
  Controls Design	
  Verification
• Design	
  Inputs	
  must	
  be	
  clear	
  
(unambiguous)	
  and	
  verifiable.
• Design	
  Outputs	
  must	
  be	
  defined	
  so	
  that	
  
conformance	
  to	
  Design	
  Inputs	
  may	
  be	
  
demonstrated.
• Need	
  to	
  establish	
  “acceptance	
  criteria”.
• Establish	
  (and	
  validate)	
  Design	
  
Verification	
  methods.
820.30	
  Design	
  Controls Design	
  Validation
TESTING!!
Inspection
Analysis
Design	
  Validation	
  
Plan
Results
Design	
  Validation	
  Methods
FDA Design Controls: What Medical Device Makers Need to Know
820.30	
  Design	
  Controls Design	
  Validation
Did	
  you	
  design	
  the	
  
correct	
  medical	
  
device?
User	
  Needs Medical	
  Device Design	
  Validation
Design  Transfer
Not  an  event  – but  a  process!
Regulation Description
21CFR	
  820 Quality	
  System	
  Regulation
Subpart C Design	
  Controls
Design	
  transfer	
  is	
  the	
  translation	
  of	
  all	
  of	
  the	
  
design	
  work	
  to	
  the	
  production	
  and	
  testing	
  
processes	
  that	
  will	
  make	
  it	
  commercial-­‐izable.
820.30	
  Design	
  Controls Design	
  Transfer
• Myth:	
  	
  Design	
  Transfer	
  is	
  an	
  event
• Reality:	
  	
  Design	
  Transfer	
  is	
  an	
  iterative,	
  continuous	
  process
• Myth:	
  	
  Design	
  Transfer	
  is	
  Operations’	
  responsibility
• Reality:	
  	
  Design	
  Transfer	
  is	
  a	
  collaborative	
  effort	
  between	
  all	
  
of	
  the	
  functions	
  involved	
  in	
  design	
  and	
  development
• Myth:	
  	
  Design	
  Transfer	
  occurs	
  after	
  “design	
  freeze”
• Reality:	
  	
  Design	
  Transfer	
  begins	
  early	
  in	
  design	
  and	
  
development,	
  and	
  is	
  part	
  of	
  design	
  refinements	
  (design	
  
changes)	
  that	
  lead	
  to	
  a	
  “final”	
  design.	
  	
  Design	
  Transfer	
  can	
  not	
  
end	
  until	
  the	
  DMR	
  is	
  finalized.
Design	
  Transfer	
  Myths
820.30	
  Design	
  Controls Design	
  Transfer
Source	
  of	
  Misconceptions
21	
  CFR	
  Part	
  820.30	
  Design	
  Control
b) Design	
  &	
  Development	
  Planning
c) Design	
  Input
d) Design	
  Output
e) Design	
  Review
f) Design	
  Verification
g) Design	
  Validation
h) Design	
  Transfer
i) Design	
  Changes
Which	
  gets	
  visualized	
  as:
Planning
Design	
  
Input
Design	
  
Output
Design	
  
Review
Design	
  
Verification
Design	
  
Validation
Design	
  
Transfer
But	
  the	
  process	
  really	
  looks	
  more	
  like	
  this:
Design	
  &	
  Development	
  Planning
Design	
  Input
Design	
  Output
Design	
  Verification
Design	
  Validation
Design	
  Transfer
Design	
  Review
820.30	
  Design	
  Controls Design	
  Transfer
Design	
  Transfer	
  Completion
• All	
  Device	
  Master	
  Record	
  (DMR)	
  elements	
   reviewed,	
  
approved,	
  and	
  production	
  released
• All	
  (DMR)	
  elements	
   are	
  managed	
  under	
  formal	
  
change	
  control
• Risk	
  assessments	
   completed	
   and	
  all	
  identified	
  risks	
  
appropriately	
  dispositioned
• Defined	
  and	
  implemented	
   test	
  strategy	
  for	
  incoming,	
  
in-­‐process,	
  and	
  final	
  acceptance	
   testing
• Plans	
  in	
  place	
  to	
  monitor	
  and/or	
  control	
  features	
  
identified	
  as	
  critical	
  to	
  quality
• Process	
  validation	
  complete
• Test	
  methods	
  validated	
  and	
  complete
• Inspection	
  procedures,	
  visual	
  inspections,	
   and	
  
workmanship	
  standards	
  are	
  complete
• Installation	
  and	
  servicing	
  procedures	
  are	
  complete
• All	
  equipment	
  	
  identified	
  and	
  calibrated	
  and	
  
maintenance	
   procedures	
  are	
  in	
  place
• Manufacturing	
  personnel	
  and	
  inspectors	
  have	
  been	
  
trained
• All	
  supplier	
  agreements	
   and	
  qualifications	
  are	
  
complete
• Procedures	
  in	
  place	
   to	
  ensure	
  control	
  of	
  device	
  
handling,	
  storage	
  and	
  distribution	
  of	
  product
• Procedures	
  in	
  place	
   to	
  ensure	
  identification	
  and	
  
traceability	
  of	
  product
• Design	
  verification	
  testing	
  performed	
  and	
  
demonstrates	
  design	
  outputs	
  meet	
   	
  design	
  inputs
• Design	
  validation	
  testing	
  performed	
  demonstrates	
  
design	
  meets	
  user	
  needs	
  &	
  intended	
  uses
• All	
  elements	
   of	
  the	
  Design	
  Transfer	
  Plan	
  have	
  been	
  
completed	
   or	
  otherwise	
  addressed
820.30	
  Design	
  Controls Design	
  Transfer
820.30	
  Design	
  Controls Design	
  Transfer
Discussion	
  Point:	
   a	
  process	
  should	
  identify	
  what	
  represents	
  
“accurate	
  translation”	
  of	
  the	
  device	
  design.
“There	
  is	
  no	
  assurance	
  that	
  a	
  design	
  transfer	
  procedure	
  
has	
  been	
  adequately	
  established	
  for	
  [PRODUCT]	
  to	
  […]	
  
ensure	
  an	
  accurate	
  translation	
   of	
  the	
  device	
  design	
  and	
  
conformance	
  to	
  predefined	
  user	
  needs	
  and	
  intended	
  
uses.	
  	
  
There	
  is	
  no	
  assurance	
  that	
  design	
  transfer	
  procedures	
  
have	
  been	
  adequately	
  established	
  for	
  each	
  
rework/reconfiguration	
   process	
  of	
  Passport	
  V	
  Monitor	
  to	
  
ensure	
  an	
  accurate	
  translation	
   of	
  the	
  device	
  design.”
Regulatory  Submissions
The  DHF  forms  the  basis  for  your  objective  evidence  
that  the  device  has  been  designed  to  be
safe  and  effective
Who	
  are	
  the	
  regulators?
United	
  States
European	
  Union
DOJ	
  enforcement
US	
  Device	
  
Classifications
21	
  CFR	
  860
• Classified	
  according	
  to	
  risk	
  and	
  
“criticality”	
  to	
  patient/	
  end-­‐user
• (3)	
  letter	
  code	
  groupings	
  with	
  names	
  
and	
  attributes
• Used	
  to	
  track	
  adverse	
  events	
  and	
  
field	
  actions
• As	
  new	
  classification	
  product	
  codes	
  
are	
  created,	
  a	
  device	
  may	
  be	
  re-­‐
assigned	
  into	
  a	
  new	
  product	
  code.	
  
• Guidance	
  exists	
  for	
  identifying	
  the	
  
scope	
  and	
  critical	
  aspects	
  of	
  a	
  
product	
  code.
Class	
  I Class	
  II Class	
  III
not	
  intended	
  to	
  help	
  
support	
  or	
  sustain	
  life	
  or	
  be	
  
substantially	
  important	
  in	
  
preventing	
  impairment	
  to	
  
human	
  health,	
  and	
  may	
  not	
  
present	
  an	
  unreasonable	
  
risk	
  of	
  illness	
  or	
  injury
more	
  critical	
  than	
  Class	
  I	
  
but	
  designed	
  to	
  perform	
  as	
  
indicated	
  without	
  causing	
  
injury	
  or	
  harm	
  to	
  patient	
  or	
  
user.
support	
  or	
  sustain	
  human	
  
life,	
  are	
  of	
  substantial	
  
importance	
  in	
  preventing	
  
impairment	
  of	
  human	
  
health,	
  or	
  present	
  a	
  
potential,	
  unreasonable	
  risk	
  
of	
  illness	
  or	
  injury
LOW	
  RISK MEDIUM RISK HIGH	
  RISK
General	
  Controls General	
  Controls	
  	
  +	
  
Special	
  Controls
510(k)
General	
  Controls	
  
+	
  Premarket	
  Approval	
  
(PMA)
General	
  Controls
• Basic	
  requirements	
  for	
  all	
  medical	
  device	
  companies	
  per	
  MDA
• Applies	
  to	
  all devices;	
  Class	
  I	
  only has	
  to	
  follow	
  general	
  
controls	
  (with	
  some	
  exceptions)
• Includes	
  provisions:
• Adulteration
• Misbranding
• Device	
  registration	
  and	
  listing
• Premarketing	
  notification	
  (exemptions	
  in	
  XXX.9s)
• Banned	
  devices
• Notification	
  – repair,	
  replacement,	
  refund
• Records	
  and	
  reports
• Restricted	
  devices
• GMPs	
  (Quality	
  System	
  Regulation)-­‐ some	
  exemption
Class	
  I Class	
  II Class	
  III
Why	
  do	
  I	
  need	
  to	
  comply	
  to	
  ISO	
  13485?
Submitting	
  a	
  
Medical	
  Device	
  in	
  
United	
  States
General	
  controls	
  +	
  510(k)	
  or	
  PMA	
  
depending	
  on	
  risk	
  and	
  intended	
  use	
  
of	
  device
Implement	
  a	
  quality	
  management	
  
system
21	
  CFR	
  820	
  (QSR)
Registration	
  &	
  
Submission
Pre-­‐market	
  
notification
The	
  2	
  main	
  pathways	
  of	
  getting	
  to	
  US	
  market.
Pre-­‐market	
  
approval	
  (PMA)
The	
  510(k)	
  – Substantial	
  Equivalence
Substantial
Equivalence
Technological	
  
Characteristics
Intended	
  Use= &
or
Different	
  
Technological	
  
Characteristics
No	
  new	
  safety	
  	
  or	
  
efficacy	
  concerns
+
Pre-­‐market	
  
notification
Traditional
Special	
  (20%)
Abbreviated	
  (5%)
510(k)	
  Content	
  (21	
  CFR	
  807.87)
• Admin	
  paperwork	
  (cover	
  pages,	
  statements
• Device	
  information:	
  name,	
  intended	
  use,	
  classification
• Company	
  information:	
  location,	
  certifications
• Labeling	
  
• Substantial	
  equivalence	
  assessment
o Device	
  specifications	
  and	
  reference	
  applicable	
  guidance	
  documents,	
  
special	
  controls,	
  or	
  standards;	
  photographs	
  or	
  engineering	
  drawings
o Testing	
  data
o Comparison	
  charts
• Information	
  on	
  biocompatibility,	
  sterilization,	
  materials	
  analysis,	
  
etc.
510(k)	
  Data
http://www.emergogroup.com/resources/research/fda-­‐510k-­‐review-­‐times-­‐research
The	
  SE	
  Letter.
Q&A
Part  2
David  Amor
@medgineering
david@medgineering.com
786.546.1806
www.medgineering.com
www.21cfr820.com
www.myquickconsult.com
Jon  Speer
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
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FDA Design Controls: What Medical Device Makers Need to Know

  • 1. The  Complete  Guide  to   FDA  Design  Controls Part  1  &  2 April  26th,  2016
  • 2. About  the  Presenter David  Amor  is  the  co-­‐founder  and  CEO   of  Medgineering  &  QuickConsult. • Adjunct  Professor,  St.  Cloud  State   University  (SCSU)  – MTQ628   Design  Controls • 9+  years  of  QA/RA  consulting   including  DHF  /  risk  mgmt remediation  projects • FDA  &  EU  expert  in  QMS @medgineering david@medgineering.com 786.546.1806 Medgineering  is  a  medtech consulting  firm   based  in  Minneapolis,  MN  focusing  on   regulatory  submissions  and  quality  systems. www.medgineering.com www.21cfr820.com Online  medtech consulting  marketplace  – on   demand  experts  for  Q&A  and  projects! www.myquickconsult.com
  • 3. About  the  Presenter Jon  Speer  is  the  Founder  &  VP  QA/RA   of  greenlight.guru. • 17+  years  in  medical  device  industry • Product  development  engineer,   quality  manager,  regulatory   specialist • 40+  products  to  market • Expert  at  QMS  implementations • Dozens  of  ISO  audits  &  FDA   inspections @creoquality @greenlightguru Jon.Speer@greenlight.guru +1  317  960  4280 greenlight.guru   produces  beautifully  simple   quality,  design  control  and  risk  management   software  exclusively  for  medical  device   manufacturers.  We  help  you  bring  higher   quality  devices  to  market  faster  and  with  less   risk. http://greenlight.guru
  • 4. In  Part  1,  you'll  learn  about  Intended  Use,  User  Needs,  Design   Inputs,  Design  Reviews,  Design  History  File  (DHF)  and  Risk   Management. Specifically: • The  importance  of  getting  your  intended  use  right  up  front • The  difference  between  a  user  need  and  a  design  input   that's  verifiable • What  stakeholders  need  to  be  involved  in  the  process  and   why • When  and  how  many  design  reviews  you  should  hold • Why  FMEA  alone  is  NOT  risk  management  and  how  to   integrate  risk  into  the  design  and  development  process
  • 5. In  Part  2,  you'll  learn  about  Design  Outputs,  Device  Master   Record  (DMR),  Design  Verification  and  Validation  (V&V),   Design  Transfer  and  Regulatory  Submissions. Specifically: • Why  your  design  outputs  need  to  be  more  than  a  drawing   and  their  relationship  to  your  DMR • How  usability  and  human  factors  fits  into  the  overall  product   development • Making  sure  you  build  the  correct  device  and  build  it   correctly  with  design  V&V • Common  mistakes  people  make  during  design  transfer  to   production  and  how  to  avoid  them • When  you  can  and  should  make  your  regulatory  submission
  • 10. Design  Controls  – when? Any  Class  II  or  Class  III  medical  device  developed  in  the   US  – part  of  quality  system  (QMS). Investigational  Device  Exemption  (IDE)  – 21  CFR  812.
  • 14. User  Needs  &  Design  Input The  FDA  differentiates  between user  needs  and  technical  requirements
  • 15. Regulation Description 21CFR  820 Quality  System  Regulation Subpart C Design  Controls Use  a  development  plan.  Keep  it  short  and   sweet.  Don’t  overcommit  and  don’t  make  it  too   prescriptive. 820.30  Design  Controls Design  Planning
  • 16. 820.30  Design  Controls Design  Planning The  extent  of  design  and   development  planning  should   reflect  company  size  and   complexity  and  any  outsourcing. • Refining  is  OK  – especially  for  new   portfolio  products • Identify  key  milestones  and  dates  only • Detail  should  be  dependent  on  risk • If  outsourcing  development  work,   identify  the  resources  and  integration
  • 17. 820.30  Design  Controls Design  Planning “You  state  in  your  response  that  you  plan  on  making  your   design  plan  more  robust.  We  would  like  to  clarify  that  this   plan,  as  per  21  CFR  820.30(b),  “shall  identify  and  describe  the   interface  between  groups  that  provide,  or  result  in,  input  to   the  design  development  process.  The  plans  shall  be   reviewed,  updated,  and  approved  as  design  and   development  evolves.”  The  design  plan  for  Avex  CX2  and   CXi2,  reviewed  during  the  current  inspection,  was  observed   to  lack  this  data  including,  but  not  limited  to,  completed  and   approved  plans  for:  Development,  Clinical,  Risk  Management,   Quality  Processing,  Manufacturing,  and  Manufacturing   Qualification” Discussion   Point:  Lack  of  documented  planning  shows  poor  oversight   of  your  processes.  Development  planning  may  change  with  new   information  – up  to  the  point  of  design  freeze.
  • 18. Regulation Description 21CFR  820 Quality  System  Regulation Subpart C Design  Controls Design  inputs  need  to  be  organized  and   differentiated  between  users,  customers  and   stakeholders.  Design  inputs  must  be  clear  and   verifiable. 820.30  Design  Controls Design  Inputs
  • 19. 820.30  Design  Controls Design  Inputs Design  requirements  are  the  single   most  important  factor  in  820.30 “There’s  never  time  to  do  it  right  but   there’s  always  time  to  do  it  over!” • Comprehensive  – per  risk • Methodical • Linked  to  clinical  or  other  rationale
  • 20. 820.30  Design  Controls Design  Inputs “Drilling  down”  inputs  is  critical. • Refining  is  OK  – especially  for  new   portfolio  products • Identify  key  milestones  and  dates  only • Detail  should  be  dependent  on  risk • If  outsourcing  development  work,   identify  the  resources  and  integration
  • 21. 820.30  Design  Controls Design  Inputs “Drilling  down”  inputs  is  critical. User  Needs Marketing   Needs Customer   Needs Other   Stakeholder   Needs “Concept”  Documents  per  FDA   Guidance  1997  Design  Controls
  • 22. 820.30  Design  Controls Design  Inputs Am  I  ever  going  to  tell  you   that  I  need  a  catheter   with  a  tensile  strength  of   10  +/-­‐ 2  N? “Drilling  down”  inputs  is  critical. User  Needs Marketing   Needs Customer   Needs Other   Stakeholder   Needs
  • 23. 820.30  Design  Controls Design  Inputs Product   Requirements • Solution  independent • Clear • Concise • Verifiable “Drilling  down”  inputs  is  critical. User  Needs Marketing   Needs Customer   Needs Other   Stakeholder   Needs
  • 24. 820.30  Design  Controls Design  Inputs “Drilling  down”  inputs  is  critical. User  Needs Marketing   Needs Customer   Needs Other   Stakeholder   Needs Product   Requirements Specifications WHAT? HOW!
  • 25. 820.30  Design  Controls Design  Inputs The  catheter  shall   be  easy  to   manipulate. The  catheter  shall   have  a  torque  ratio   of  1:1   User  Need (Requirement) Design  Input (Requirement) Design  Output (Specification) Material  specifications Test  methods Drawings
  • 26. 820.30  Design  Controls Design  Inputs Design  Input (Requirement) The  catheter  shall   have  a  torque  ratio   of  1:1   This  may  involve  iterative   testing  until  the  design  input   requirement  is  determined. • TBD  in  initial  drafts  of  DI   documents  are  acceptable  – help  guide  feasibility  testing! • May  shift  over  time • Impact  assessment
  • 27. 820.30  Design  Controls Design  Inputs “Failure  to  establish  and  maintain   adequate  procedures  to  ensure  that  the   design  requirements  relating  to  a  device   are  appropriate  and  address  the  intended   use  of  the  device,  including  the  needs  of   the  user  and  patient,  as  required  by  21  CFR   820.30(c)” Discussion  Point:  When  you  create  a  user  needs  /  requirement   document,  are  you  linking  it  back  to  the  intended  use  of  the   device?  
  • 28. 820.30  Design  Controls Design  Inputs Design  Inputs  must  be  clear   (unambiguous)  and  verifiable. • If  basing  design  inputs  on  a  standard,   make  sure  the  standard  reference  is   specific,  clear,  and  test-­‐able • When  you  think  of  design  inputs,  think   “engineering”  and  “getting  technical” • Find  a  resource  for  writing  requirements
  • 29. 820.30  Design  Controls Design  Inputs Design  Inputs  must  be  clear   (unambiguous)  and  verifiable. “Device  shall  be  portable”….
  • 30. 820.30  Design  Controls Design  Inputs Design  Inputs  must  be  clear   (unambiguous)  and  verifiable. “Device  shall  be  compliant  to  ISO  10993-­‐1…”
  • 31. 820.30  Design  Controls Design  Inputs Design  Inputs  must  be  clear   (unambiguous)  and  verifiable. Device  shall  be  flexible Device  shall  be  formed  into  a  50  mm   diameter  coil  and  straightened  out  for   a  total  of  50  times  with  no  evidence  of   cracking  or  deformity. NOTE: assess  the  level  of  granularity  or  detail  based  on  requirement   criticality/  risk. VS
  • 32. 820.30  Design  Controls Design  Inputs F  P  I  S. • Functional:  what  does  the  device  do? • Performance:  accuracy,  conditions,   operational  limits,  reliability,  etc. • Interface:  what  does  the  device  need  to  have   to  work  with  accessories  or  external  items? • Safety:  does  the  device  need  precautionary   measures  or  safety  margins?
  • 33. A  note  on  drafting  requirements. • Language  is  important a) ‘Shall’  vs.  ‘Should’ a) “Must  have”  vs.  “Nice  to  have” b) Avoid  “as  applicable”  or  “as  required”  in  final  DI   • Avoid  contradicting  requirements • System  à sub-­‐system a) Particularly  useful  for  contracting 820.30  Design  Controls Design  Inputs
  • 34. A  note  on  drafting  requirements. • Avoid  comparative  requirements • Ex:  “…shall  be  20%  better  than  the  predicate.” • Avoid  multiple  objectives  in  same  requirement • Avoid  “NOTEs”!!! • INCOSE  “Writing  technical  requirements” 820.30  Design  Controls Design  Inputs
  • 35. 820.30  Design  Controls Design  Inputs Don’t  stress  about  documenting   design  inputs  in  proof  of  concept  or   feasibility  phases.  Be  agile! • FDA  distinguishes  between  R&D  and   finished  product  – remember  this!   • Design  inputs  apply  to  the   commercial  product  (“how  do  I  know   the  design  is  in  control?”)
  • 36. The  importance  of  traceability. “Failure  to  establish  and  maintain   adequate  procedures  for  verifying  the   device  design,  as  required  by  21  CFR   820.30(f).  Specifically,  design  outputs  were   not  always  evaluated  to  demonstrate  that   the  outputs  met  design  inputs.”
  • 39. Risk  Management Design  Controls Intended  Use  is  important  for   Design  Controls  &  Risk   Management. Risk  Management  &  Design  Controls   are  about  demonstrating  a  medical   device  is  SAFE  and  EFFECTIVE.
  • 40. Risk  Management Design  Controls Product  Risk  Management  is  a   cycle,  even  during  product   development. • Start  Risk  Management  process  early • Use  Risk  Management  process  to   improve  product  design • Use  Design  Controls  to  support  Risk   Controls  /  Mitigations
  • 42. RISK  MANAGEMENT-­‐ systematic  application  of  management   policies,  procedures,  and  practices  to  the  tasks  of  analyzing,   evaluating,  controlling,  and  monitoring  risk RISK -­‐ combination  of  the  probability  of  occurrence  of  harm   and  the  severity  of  that  harm ISO  14971  Risk  Management Key  Terms
  • 43. HAZARD -­‐ potential  source  of  harm HAZARDOUS  SITUATION -­‐ circumstance  in  which  people,   property,  or  the  environment  are  exposed  to  one  or  more   hazard(s) HARM -­‐ physical  injury  or  damage  to  the  health  of  people,  or   damage  to  property  or  the  environment SEVERITY -­‐ measure  of  the  possible  consequences  of  a  hazard ISO  14971  Risk  Management Key  Terms
  • 44. RISK  ANALYSIS -­‐ systematic  use  of  available  information  to   identify  hazards  and  to  estimate  the  risk RISK  ESTIMATION -­‐ process  used  to  assign  values  to  the   probability  of  occurrence  of  harm  and  the  severity  of  that  harm RISK  EVALUATION -­‐ process  of  comparing  the  estimated  risk   against  given  risk  criteria  to  determine  the  acceptability  of  the   risk RISK  ASSESSMENT -­‐ overall  process  comprising  a  risk  analysis   and  a  risk  evaluation RISK  CONTROL -­‐ process  in  which  decisions  are  made  and   measures  implemented  by  which  risks  are  reduced  to,  or   maintained  within,  specified  levels RESIDUAL  RISK -­‐ risk  remaining  after  risk  control  measures   have  been  taken ISO  14971  Risk  Management Key  Terms
  • 45. ISO  14971  Risk  Management Process  Overview
  • 46. ISO  14971  Risk  Management Establish  Framework
  • 47. ISO  14971  Risk  Management Risk  Analysis
  • 48. ISO  14971  Risk  Management Risk  Analysis I  can  be  a  valuable   resource  throughout  the   Risk  Management   Process! Include  end-­‐users  as  part  of  the   process. Hazards Foreseeable   Sequence  of   Events Hazardous   Situations Harms
  • 49. ISO  14971  Risk  Management Risk  Evaluation
  • 50. ISO  14971  Risk  Management Risk  Evaluation Risk  Evaluation  criteria  shall  be   established  and  should  be  specific   to  your  product.   • Use  sources  like  MAUDE  and  other   industry  databases. • Consult  with  end-­‐users  to  understand   true  severity. • Evaluate  other  similar  products. • Leverage  standards  and  guidance   documents.
  • 51. ISO  14971  Risk  Management Risk  Assessment
  • 52. ISO  14971  Risk  Management Risk  Assessment
  • 53. ISO  14971  Risk  Management Risk  Control
  • 54. ISO  14971  Risk  Management Risk  Control Risk  Controls  are  means  to   demonstrate  risks  have  been   reduced  to  acceptable  levels.   Priority  of  Risk  Control  options: 1. Inherent  safety  by  design 2. Protective  measures  in  the  medical   device  itself  or  in  the  manufacturing   process. 3. Information  for  safety. Recommend  identifying  Risk  Controls  for   ALL risks.
  • 55. ISO  14971  Risk  Management Risk  Control My  Design  Outputs,   Design  Verifications,   and  Design  Validations   can  be  used  as  Risk   Control  Measures.
  • 57. ISO  14971  Risk  Management Risk  Acceptability
  • 58. ISO  14971  Risk  Management Risk  Acceptability Have  me  help  you   with  risk  /  benefit   analysis  of  your   product. Medical  benefits  of  the  medical   device  need  to  outweigh  the  risks  to   patients  and  end-­‐users.
  • 59. ISO  14971  Risk  Management Risk  Management  Report
  • 60. ISO  14971  Risk  Management Production  /  Post-­‐Production
  • 62. Regulation Description 21CFR  820 Quality  System  Regulation Subpart C Design  Controls Design  reviews  shall  be  planned  and  conducted   at  appropriate  stages  during  medical  device   product  development. 820.30  Design  Controls Design  Review
  • 63. 820.30  Design  Controls Design  Review “Failure  to  document  the  design  review  results,  including   the  date,  in  the  design  history  file,  as  required  by  21  CFR   820.30(e).” “Design  reviews  were  not  performed  and/or  documented   for  the  .  .  .design  project  as  required  in  the  work   instruction  or  the  design  plan.” “Design  reviews  were  conducted;  however,  the  records  fail   to  indicate  the  date  or  dates  the  design  reviews  were   conducted  and  fail  to  indicate  the  results  of  the  design   reviews  as  required  in  the  work  instruction. “However,  there  were  no  records  of  any  design  reviews   having  been  conducted  after  the  design  changes  were   implemented  or  transferred  to  production.”
  • 64. 820.30  Design  Controls Design  Review Timing  of  design  reviews  is  a   function  of  design  planning.   Frequency  of  design  reviews  should   reflect  complexity  of  product   development. • All  design  controls  need  to  be  part  of   design  reviews. • Design  plan  shall  identify  when  design   reviews  are  to  happen. • Design  reviews  shall  include  an   “independent  reviewer”. • Design  reviews  shall  include  appropriate   functions.
  • 66. Design  History  File What  goes  in  DHF?
  • 67. Regulation Description 21CFR  820 Quality  System  Regulation Subpart C Design  Controls DHF  contains  documented  evidence  that   medical  device  was  developed  according  to   established  design  plan. DHF  contains  all  design  controls. 820.30  Design  Controls Design  History  File  (DHF)
  • 68. 820.30  Design  Controls Design  History  File  (DHF) “Failure  to  establish  and  maintain  a  design   history  file  for  each  type  of  device,  as   required  by  21  CFR  820.30(j). For  example,   your  firm  was  unable  to  demonstrate  when   key  elements  of  a  design  history  file  for  the   design  project  were  conducted  and   approved,  such  as  design  inputs,  outputs,   verification,  validation,  and  design   transfer.”
  • 69. 820.30  Design  Controls Design  History  File  (DHF) If  it  isn’t  documented,  then  it  didn’t   happen.   Document  all  Design  Controls  and   keep  records  in  an  organized  DHF. • Establish  a  DHF  per  product. • Use  Design  Reviews  to  confirm  Design   Controls  have  been  documented.   • Compile  DHF  into  a  “single  source  of   truth”.
  • 70. 820.30  Design  Controls Design  History  File  (DHF) It  is  my  responsibility   to  document  design   controls  and  maintain   the  DHF.
  • 72. David  Amor @medgineering david@medgineering.com 786.546.1806 www.medgineering.com www.21cfr820.com www.myquickconsult.com Jon  Speer @creoquality @greenlightguru Jon.Speer@greenlight.guru +1  317  960  4280 Quality  Management  Software   Exclusively  for  Med  Devices http://greenlight.guru Getting  in  Touch
  • 73. The  Complete  Guide  to   FDA  Design  Controls Part  2
  • 74. In  Part  2,  you'll  learn  about  Design  Outputs,  Device  Master   Record  (DMR),  Design  Verification  and  Validation  (V&V),   Design  Transfer  and  Regulatory  Submissions. Specifically: • Why  your  design  outputs  need  to  be  more  than  a  drawing   and  their  relationship  to  your  DMR • How  usability  and  human  factors  fits  into  the  overall  product   development • Making  sure  you  build  the  correct  device  and  build  it   correctly  with  design  V&V • Common  mistakes  people  make  during  design  transfer  to   production  and  how  to  avoid  them • When  you  can  and  should  make  your  regulatory  submission
  • 75. Design  Outputs  &  DMR Design  Outputs  – more  than  just  drawings!
  • 76. Regulation Description 21CFR  820 Quality  System  Regulation Subpart C Design  Controls Design  outputs  aren’t just  specifications  and   drawings. 820.30  Design  Controls Design  Outputs
  • 77. 820.30  Design  Controls Design  Outputs What  can  I  show  you  in  my  books  to   demonstrate  that  the  design  inputs  are  being   met/  fulfilled/  satisfied  – how  can  I  prove  it?
  • 78. • “Establish  and  maintain  procedures  for   documenting  design  output  in  terms  that   allow  an  adequate  evaluation  of   conformance  to  design  input  requirements” 820.30  Design  Controls Design  Outputs • PLAIN  ENGLISH:  “We  need  a  documented   way  to  show  how  we  show  that  our  design   inputs  are  met  – a  drawing,  a  specification,   results  of  a  test,  methods,  etc.”
  • 79. • “Design  output  procedures  shall  contain  or   make  reference  to  acceptance  criteria….” 820.30  Design  Controls Design  Outputs • PLAIN  ENGLISH:  How  do  we  know  a  design   input  requirement  is  met?  Acceptance   criteria.  The  output  must  be  clearly  marked   to  be  able  to  show  this!
  • 80. • “and  shall  ensure  that  those  design  outputs   that  are  essential  for  the  proper  functioning   of  the  device  are  identified.” 820.30  Design  Controls Design  Outputs • PLAIN  ENGLISH:  ‘Essential  for  proper   functioning’  means  you  should  know  the   Intended  Use  and  what  design  aspects  are   most  critical  to  meet  it.
  • 81. 820.30  Design  Controls Design  Outputs Design  outputs:  format   and  type Drawings Material   Specification Inspection   reports. Service   instructions. Mfg Instructions Batch   Records Testing   instructions. Software   code. QA  specs/   procedures. Packaging/   Labeling. Risk  Mgmt File Test  results.
  • 82. 820.30  Design  Controls Design  Outputs “Failure  to  establish  and  maintain   adequate  procedures  for  verifying  the   device  design,  as  required  by  21  CFR   820.30(f).  Specifically,  design  outputs  were   not  always  evaluated  to  demonstrate  that   the  outputs  met  design  inputs.” Discussion  Point:   Some  companies  use  DOORS  or  other  similar   requirements  traceability  programs  – what  are  the  pros  and   cons  with  those  programs?
  • 83. 820.30  Design  Controls Design  Outputs ”For  example,  change  summary  report,   DP#05-­‐11  – “ICL  Change  of  Packaging   Solution  from  (b)(4) to  (b)(4)”  lacks  the   necessary  attachments,  references  and   reports  necessary  to  compare  the  design   inputs  with  the  design  outputs  and   determine  the  adequacy  of  the   verification.” Discussion  Point:   Some  companies  use  DOORS  or  other  similar   requirements  traceability  programs  – what  are  the  pros  and   cons  with  those  programs?
  • 84. The  total  finished  design  output  consists  of  the   device,  its  packaging  and  labeling,  and  the   device  master  record.   820.30  Design  Controls Design  Outputs The  DMR  is  the  “one  stop  shop”  for  design   outputs,  often  maintained  in  a  DMR  Index.
  • 85. Design  Verification  &   Design  Validation An  overview
  • 87. 820.30  Design  Controls Design  Verification Did  I  design  my   medical  device   correctly?   Design  Input (Requirement) Design  Output (Specification) Design  Verification
  • 88. 820.30  Design  Controls Design  Validation Did  you  design  the   correct  medical   device? User  Needs Medical  Device Design  Validation
  • 90. 820.30  Design  Controls Design  Verification “Failure  to  establish  and  maintain  adequate  procedures   for  verifying  the  device  design. Design  verification  shall   confirm  that  the  design  output  meets  the  design  input   requirements,  as  required  by  21  CFR  820.30(f). For   example: Your  firm  failed  to  validate  test  methods  implemented   during  design  verification  testing. These  test  methods   were  created  in-­‐house  to  verify  your  firm’s  design  inputs;   however,  they  were  not  based  on  and  did  not  follow  a   national  standard. Your  firm  failed  to  follow  its  test  procedure  during  design   verification  testing. Your  firm  performed  design  verification  prior  to   establishing  design  inputs.”
  • 91. 820.30  Design  Controls Design  Validation “Your  firm  failed  to  establish  (i.e.,  define,  document,  and   implement)  and  maintain  design  validation  procedures  to   ensure  that  devices  conform  to  defined  user  needs  and   intended  uses  and  shall  include  testing  of  production  units   under  actual  or  simulated  use  conditions,   as  required  by   21  CFR  820.30(g). For  example,  your  firm  failed  to  implement  its  established   procedure  for  design  validation.  .  . However,  prior  to   commercially  releasing  your  product,   your  firm  failed  to   conduct  design  validation  of  the  device  constituent  part  of   this  combination  product,  as  required  by  your  SOP. ”
  • 92. Regulation Description 21CFR  820 Quality  System  Regulation Subpart C Design  Controls Design  Verification  demonstrates  that  the   medical  device  Design  Outputs  meet  the  Design   Inputs. 820.30  Design  Controls Design  Verification
  • 93. 820.30  Design  Controls Design  Verification Design  Verification  shall  provide   clear,  objective  evidence  that   Design  Outputs  meet  Design  Inputs • Consider  Design  Verification  when   defining  Design  Inputs • Establish  a  Design  Verification  Plan  (and   do  so  early) • Define  verification  methods • Demonstrate  acceptance  criteria  is  met
  • 94. 820.30  Design  Controls Design  Verification The  catheter  shall   have  a  torque  ratio   of  1:1   Design  Input (Requirement) Design  Output (Specification) Material  specifications Plans Drawings Design  Verification Results Methods
  • 95. 820.30  Design  Controls Design  Verification Testing Inspection Analysis Design  Verification   Plan Design  Verification  Methods
  • 97. 820.30  Design  Controls Design  Verification • Design  Inputs  must  be  clear   (unambiguous)  and  verifiable. • Design  Outputs  must  be  defined  so  that   conformance  to  Design  Inputs  may  be   demonstrated. • Need  to  establish  “acceptance  criteria”. • Establish  (and  validate)  Design   Verification  methods.
  • 98. 820.30  Design  Controls Design  Verification Testing Inspection Analysis Design  Verification   Plan Results Design  Verification  Methods
  • 100. 820.30  Design  Controls Design  Verification Did  I  design  my   medical  device   correctly?   Design  Input (Requirement) Design  Output (Specification) Design  Verification
  • 101. Regulation Description 21CFR  820 Quality  System  Regulation Subpart C Design  Controls Design  Validation  demonstrates  that  the   medical  device  meets  the  needs  of  the  end-­‐ user(s). 820.30  Design  Controls Design  Validation
  • 102. 820.30  Design  Controls Design  Validation Design  Validation  shall  provide   clear,  objective  evidence  that  the   medical  device  meets  the  needs  of   the  end-­‐users.   • Establish  a  Design  Validation  Plan  (and   do  so  early) • Use  regulatory  product  classification • Involves  “clinical  evaluation”  in  actual  or   simulated  use  with  actual  end-­‐users • Product  is  production  equivalent   • Includes  the  entire  product,  including   packaging  and  labeling
  • 103. 820.30  Design  Controls Design  Validation • “Clinical  evaluation”  does  NOT  just   mean  actual  use. • Actual  use  will  likely  require  addressing   additional  regulatory  criteria. • For  many  devices,  simulated  use  is  more   than  sufficient.
  • 104. 820.30  Design  Controls Design  Validation User  Needs Medical  Device Plans Design  Validation Results Methods The  catheter  shall   be  easy  to   manipulate.
  • 105. 820.30  Design  Controls Design  Validation TESTING!! Inspection Analysis Design  Validation   Plan Design  Validation  Methods
  • 107. 820.30  Design  Controls Design  Verification • Design  Inputs  must  be  clear   (unambiguous)  and  verifiable. • Design  Outputs  must  be  defined  so  that   conformance  to  Design  Inputs  may  be   demonstrated. • Need  to  establish  “acceptance  criteria”. • Establish  (and  validate)  Design   Verification  methods.
  • 108. 820.30  Design  Controls Design  Validation TESTING!! Inspection Analysis Design  Validation   Plan Results Design  Validation  Methods
  • 110. 820.30  Design  Controls Design  Validation Did  you  design  the   correct  medical   device? User  Needs Medical  Device Design  Validation
  • 111. Design  Transfer Not  an  event  – but  a  process!
  • 112. Regulation Description 21CFR  820 Quality  System  Regulation Subpart C Design  Controls Design  transfer  is  the  translation  of  all  of  the   design  work  to  the  production  and  testing   processes  that  will  make  it  commercial-­‐izable. 820.30  Design  Controls Design  Transfer
  • 113. • Myth:    Design  Transfer  is  an  event • Reality:    Design  Transfer  is  an  iterative,  continuous  process • Myth:    Design  Transfer  is  Operations’  responsibility • Reality:    Design  Transfer  is  a  collaborative  effort  between  all   of  the  functions  involved  in  design  and  development • Myth:    Design  Transfer  occurs  after  “design  freeze” • Reality:    Design  Transfer  begins  early  in  design  and   development,  and  is  part  of  design  refinements  (design   changes)  that  lead  to  a  “final”  design.    Design  Transfer  can  not   end  until  the  DMR  is  finalized. Design  Transfer  Myths 820.30  Design  Controls Design  Transfer
  • 114. Source  of  Misconceptions 21  CFR  Part  820.30  Design  Control b) Design  &  Development  Planning c) Design  Input d) Design  Output e) Design  Review f) Design  Verification g) Design  Validation h) Design  Transfer i) Design  Changes Which  gets  visualized  as: Planning Design   Input Design   Output Design   Review Design   Verification Design   Validation Design   Transfer But  the  process  really  looks  more  like  this: Design  &  Development  Planning Design  Input Design  Output Design  Verification Design  Validation Design  Transfer Design  Review 820.30  Design  Controls Design  Transfer
  • 115. Design  Transfer  Completion • All  Device  Master  Record  (DMR)  elements   reviewed,   approved,  and  production  released • All  (DMR)  elements   are  managed  under  formal   change  control • Risk  assessments   completed   and  all  identified  risks   appropriately  dispositioned • Defined  and  implemented   test  strategy  for  incoming,   in-­‐process,  and  final  acceptance   testing • Plans  in  place  to  monitor  and/or  control  features   identified  as  critical  to  quality • Process  validation  complete • Test  methods  validated  and  complete • Inspection  procedures,  visual  inspections,   and   workmanship  standards  are  complete • Installation  and  servicing  procedures  are  complete • All  equipment    identified  and  calibrated  and   maintenance   procedures  are  in  place • Manufacturing  personnel  and  inspectors  have  been   trained • All  supplier  agreements   and  qualifications  are   complete • Procedures  in  place   to  ensure  control  of  device   handling,  storage  and  distribution  of  product • Procedures  in  place   to  ensure  identification  and   traceability  of  product • Design  verification  testing  performed  and   demonstrates  design  outputs  meet    design  inputs • Design  validation  testing  performed  demonstrates   design  meets  user  needs  &  intended  uses • All  elements   of  the  Design  Transfer  Plan  have  been   completed   or  otherwise  addressed 820.30  Design  Controls Design  Transfer
  • 116. 820.30  Design  Controls Design  Transfer Discussion  Point:   a  process  should  identify  what  represents   “accurate  translation”  of  the  device  design. “There  is  no  assurance  that  a  design  transfer  procedure   has  been  adequately  established  for  [PRODUCT]  to  […]   ensure  an  accurate  translation   of  the  device  design  and   conformance  to  predefined  user  needs  and  intended   uses.     There  is  no  assurance  that  design  transfer  procedures   have  been  adequately  established  for  each   rework/reconfiguration   process  of  Passport  V  Monitor  to   ensure  an  accurate  translation   of  the  device  design.”
  • 117. Regulatory  Submissions The  DHF  forms  the  basis  for  your  objective  evidence   that  the  device  has  been  designed  to  be safe  and  effective
  • 118. Who  are  the  regulators? United  States European  Union DOJ  enforcement
  • 119. US  Device   Classifications 21  CFR  860 • Classified  according  to  risk  and   “criticality”  to  patient/  end-­‐user • (3)  letter  code  groupings  with  names   and  attributes • Used  to  track  adverse  events  and   field  actions • As  new  classification  product  codes   are  created,  a  device  may  be  re-­‐ assigned  into  a  new  product  code.   • Guidance  exists  for  identifying  the   scope  and  critical  aspects  of  a   product  code.
  • 120. Class  I Class  II Class  III not  intended  to  help   support  or  sustain  life  or  be   substantially  important  in   preventing  impairment  to   human  health,  and  may  not   present  an  unreasonable   risk  of  illness  or  injury more  critical  than  Class  I   but  designed  to  perform  as   indicated  without  causing   injury  or  harm  to  patient  or   user. support  or  sustain  human   life,  are  of  substantial   importance  in  preventing   impairment  of  human   health,  or  present  a   potential,  unreasonable  risk   of  illness  or  injury LOW  RISK MEDIUM RISK HIGH  RISK General  Controls General  Controls    +   Special  Controls 510(k) General  Controls   +  Premarket  Approval   (PMA)
  • 121. General  Controls • Basic  requirements  for  all  medical  device  companies  per  MDA • Applies  to  all devices;  Class  I  only has  to  follow  general   controls  (with  some  exceptions) • Includes  provisions: • Adulteration • Misbranding • Device  registration  and  listing • Premarketing  notification  (exemptions  in  XXX.9s) • Banned  devices • Notification  – repair,  replacement,  refund • Records  and  reports • Restricted  devices • GMPs  (Quality  System  Regulation)-­‐ some  exemption
  • 122. Class  I Class  II Class  III
  • 123. Why  do  I  need  to  comply  to  ISO  13485? Submitting  a   Medical  Device  in   United  States General  controls  +  510(k)  or  PMA   depending  on  risk  and  intended  use   of  device Implement  a  quality  management   system 21  CFR  820  (QSR) Registration  &   Submission
  • 124. Pre-­‐market   notification The  2  main  pathways  of  getting  to  US  market. Pre-­‐market   approval  (PMA)
  • 125. The  510(k)  – Substantial  Equivalence Substantial Equivalence Technological   Characteristics Intended  Use= & or Different   Technological   Characteristics No  new  safety    or   efficacy  concerns +
  • 127. 510(k)  Content  (21  CFR  807.87) • Admin  paperwork  (cover  pages,  statements • Device  information:  name,  intended  use,  classification • Company  information:  location,  certifications • Labeling   • Substantial  equivalence  assessment o Device  specifications  and  reference  applicable  guidance  documents,   special  controls,  or  standards;  photographs  or  engineering  drawings o Testing  data o Comparison  charts • Information  on  biocompatibility,  sterilization,  materials  analysis,   etc.
  • 131. David  Amor @medgineering david@medgineering.com 786.546.1806 www.medgineering.com www.21cfr820.com www.myquickconsult.com Jon  Speer @creoquality @greenlightguru Jon.Speer@greenlight.guru +1  317  960  4280 Quality  Management  Software   Exclusively  for  Med  Devices http://greenlight.guru Getting  in  Touch