“FDA’s role in regulating medical devices: premarket and scientific research programs”
Dr.
Yuan
Fang
Regulatory
Scientist,
U.S.
Food
and
Drug
Administration
(FDA)
Abstract:
The
Center
for
Devices
and
Radiological
Health
(CDRH)
is
a
branch
of
the
U.S.
Food
and
Drug
Administration
(FDA)
responsible
for
the
premarket
approval
of
all
medical
devices
in
the
U.S.,
as
well
as
the
postmarket
and
compliance
aspects
by
overseeing
the
manufacturing,
effectiveness
and
safety
of
these
devices.
The
mission
of
CDRH
is
to
protect
and
promote
the
public
health.
In
support
of
this
mission,
a
broad
strategic
scientific
regulatory
research
program
is
in
place.
This
presentation
will
give
an
overview
of
the
premarket
approval
process
of
medical
devices,
in
particular
for
radiation-emitting
devices
such
as
diagnostic
x-ray
systems.
The
presentation
will
also
include
a
summary
of
a
research
project
conducted
in
CDRH
on
the
use
of
Monte
Carlo
methods
for
modeling
image
quality
in
semiconductor
x-ray
detectors.
Speaker
Bio:
Dr.
Yuan
Fang
received
his
BASc
and
PhD
(Electrical
Engineering)
from
the
University
of
Waterloo.
He
is
the
recipient
of
numerous
awards
including
the
prestigious
Alexander
Graham
Bell
Canada
Graduate
Scholarship
(NSERC
CGS
D)
and
Carl
A.
Pollock
fellowship.
Dr.
Fang
currently
works
at
the
U.S.
Food
and
Drug
Administration
(FDA)
and
serves
as
a
lead
reviewer
for
premarket
approval
of
medical
devices,
specializing
in
diagnostic
x-ray
systems.
He
has
been
with
the
agency
since
2009,
and
published
over
20
scientific
journal
papers
and
refereed
conference
proceedings,
and
a
book
chapter
on
the
use
of
Monte
Carlo
methods
for
modeling
image
quality
in
semiconductor
x-ray
detectors.
Dr.
Fang
is
a
member
of
the
IEEE,
SPIE,
PEO
and
AAPM,
and
currently
a
liaison
for
the
American
Association
of
Physicists
in
Medicine
TG-150
for
acceptance
testing
and
QC
of
digital
radiography
units.
He
is
an
advocate
for
new
technologies
with
two
issued
US
patents,
and
serves
as
a
reviewer
for
journals
such
IEEE
Electron
Device
Letter,
Sensors
and
Transactions
on
Medical
Imaging.
If
you
are
interested
in
meeting
with
Dr.
Fang,
please
email
Krystina
Bednarowski
Pay
parking
available
in
lots
B
or
N
(map)
Event
is
FREE
and
there
will
be
coffee/cookies
available
Event sponsored by IEEE Electron Devices Society (IEEE EDS) and the Centre for Bioengineering and Biotechnology (CBB)