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Medical Device Packaging Handbook, Revised and Expanded
Max Sherman, Max Sherman
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eBook - PDF
Medical Device Packaging Handbook, Revised and Expanded
Max Sherman, Max Sherman
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About This Book
This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more.
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Information
1
Regulatory
Aspects
Max
Sherman
Sherman
Consulting
Services,
Inc.,
Warsaw,
Indiana
INTRODUCTION
The
major
impact
of
the
federal
Food,
Drug,
and
Cosmetic
Act
on
medical
de-
vice
manufacturers
began
with
enactment
of
the
Medical
Device
Amendments
of
1976.
However,
medical
device
legislation
officially
began
in
1938
when
the
Food
and
Drug
Act
of
1906
was
amended
to
cover
devices.
There
is
an
interest-
ing
history
and
there
are
many
milestones
inherent
in
the
development
of
food
and
drug
laws
in
the
United
States,
starting
from
the
very
simple
beginning
when
the
prototype
administration
was
housed
in
the
Department
of
Agriculture's
Bureau
of
Chemistry.
To
understand
today's
requirements,
we
should
first
re-
view
a
capsuled
history
of
food,
drug
and
device
legislation.
MILESTONES
IN
FDA
HISTORY
1879
Chief
chemist
Peter
Collier,
Division
of
Chemistry,
U.S.
Department
of
Agriculture,
began
investigating
food
and
drug
adulteration.
The
following
year
he
recommended
enactment
of
a
national
food
and
drug
law.
In
the
next
25
years
more
than
100
food
and
drug
bills
were
in-
troduced
in
Congress.
1883
Dr.
Harvey
W.
Wiley
became
chief
chemist
of
the
Bureau
of
Chem-
istry.
He
immediately
assigned
some
members
of
his
staff
to
study
the
problems
of
food
and
drug
adulteration.
1