This document outlines the FDA regulations and pathways for medical devices, explaining the definitions, classification, and approval processes involved. It describes the roles of the FDA, specifically the Center for Devices and Radiological Health, in regulating medical devices and includes details on product and company components of FDA approval. The document emphasizes the importance of quality management systems for manufacturers and highlights various approval pathways, such as the 510(k) process and De Novo applications.

1. Confiden'al
FDA
Regula+ons
and
Medical
Device
Pathways
to
Market
Russ
King
President
(919)
313-­‐3962
rking@methodsense.com
The contents of this presentation is not intended as and should not be
interpreted as regulatory advice for any specific product or company.

2. 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.

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. Confiden'al
Q&A
Q&A
Discussion
/
Q&A

15. Confiden'al
Thank
you.
Russ
King
President
(919)
313-­‐3962
rking@methodsense.com