nos
argued
decided
june
justice
stevens
announced
judgment
delivered
opinion
respect
parts
ii
iii
vii
opinion
respect
parts
iv
vi
justice
kennedy
justice
souter
justice
ginsburg
join
congress
enacted
medical
device
amendments
words
statute
preamble
provide
safety
effectiveness
medical
devices
intended
human
use
stat
question
presented
whether
statute
state
common
law
negligence
action
manufacturer
allegedly
defective
medical
device
specifically
must
consider
whether
lora
lohr
injured
pacemaker
failed
may
rely
florida
common
law
recover
damages
medtronic
manufacturer
device
throughout
history
several
exercised
police
powers
protect
health
safety
citizens
primarily
historically
matter
local
concern
hillsborough
county
automated
medical
laboratories
traditionally
great
latitude
police
powers
legislate
protection
lives
limbs
health
comfort
quiet
persons
metropolitan
life
ins
massachusetts
internal
quotation
marks
omitted
despite
prominence
matters
public
health
safety
recent
decades
federal
government
played
increasingly
significant
role
protection
health
people
congress
first
significant
enactment
field
public
health
food
drug
act
broad
prohibition
manufacture
shipment
interstate
commerce
adulterated
misbranded
food
drug
see
stat
regier
struggle
federal
food
drugs
legislation
law
contemp
probs
partly
response
ongoing
concern
radio
newspaper
advertising
making
false
therapeutic
claims
quack
machines
legitimate
devices
surgical
instruments
orthopedic
shoes
congress
broadened
coverage
act
include
misbranded
adulterated
medical
devices
cosmetics
see
federal
food
drug
cosmetic
act
fdca
stat
cavers
food
drug
cosmetic
act
legislative
history
substantive
provisions
law
contemp
probs
fdca
provided
approval
new
drugs
cavers
law
contemp
authorize
control
introduction
new
medical
devices
see
pp
technologies
advanced
medicine
relied
increasing
degree
vast
array
medical
equipment
rom
bedpans
brainscans
including
kidney
dialysis
units
artificial
heart
valves
heart
pacemakers
policymakers
public
became
concerned
increasingly
severe
injuries
resulted
failure
devices
see
generally
finck
effectiveness
fda
medical
device
regulation
rev
example
dalkon
shield
intrauterine
contraceptive
device
introduced
american
public
throughout
world
touted
safe
effective
contraceptive
dalkon
shield
resulted
disturbingly
high
percentage
inadvertent
pregnancies
serious
infections
even
cases
death
regulation
medical
devices
intrauterine
contraceptive
devices
hearings
subcommittee
house
committee
government
operations
sess
early
several
devices
including
catheters
artificial
heart
valves
defibrillators
pacemakers
including
pacemakers
manufactured
petitioner
medtronic
attracted
attention
consumers
fda
congress
possible
health
risks
see
medical
device
amendments
hearings
subcommittee
health
senate
committee
labor
public
welfare
response
mounting
consumer
regulatory
concern
congress
enacted
statute
issue
medical
device
amendments
mda
act
stat
act
classifies
medical
devices
three
categories
based
risk
pose
public
devices
present
unreasonable
risk
illness
injury
designated
class
subject
minimal
regulation
general
controls
devices
potentially
harmful
designated
class
ii
although
may
marketed
without
advance
approval
manufacturers
devices
must
comply
federal
performance
regulations
known
special
controls
finally
devices
either
present
potential
unreasonable
risk
illness
injury
purported
represented
use
supporting
sustaining
human
life
use
substantial
importance
preventing
impairment
human
health
designated
class
iii
pacemakers
class
iii
devices
see
cfr
new
class
iii
device
may
introduced
market
manufacturer
must
provide
fda
reasonable
assurance
device
safe
effective
see
despite
relatively
innocuous
phrasing
process
establishing
reasonable
assurance
known
premarket
approval
pma
process
rigorous
one
manufacturers
must
submit
detailed
information
regarding
safety
efficacy
devices
fda
reviews
spending
average
hours
submission
hearings
subcommittee
health
environment
house
committee
energy
commerce
sess
ser
hereinafter
hearings
see
generally
kahan
premarket
approval
versus
premarket
notification
different
routes
market
food
drug
cosm
even
class
iii
devices
market
today
received
premarket
approval
two
important
exceptions
pma
requirement
first
congress
realized
existing
medical
devices
withdrawn
market
fda
completed
pma
analysis
devices
statute
therefore
includes
grandfathering
provision
allows
devices
remain
market
without
fda
approval
time
fda
initiates
completes
requisite
pma
see
cfr
second
prevent
manufacturers
grandfathered
devices
monopolizing
market
new
devices
clear
pma
hurdle
ensure
improvements
existing
devices
rapidly
introduced
market
act
also
permits
devices
substantially
equivalent
devices
avoid
pma
process
see
although
substantially
equivalent
class
iii
devices
may
marketed
without
rigorous
pma
review
new
devices
well
new
class
class
ii
devices
subject
requirements
section
imposes
limited
form
review
every
manufacturer
intending
market
new
device
requiring
submit
premarket
notification
fda
process
also
known
process
number
section
original
act
fda
concludes
basis
notification
device
substantially
equivalent
device
marketed
without
regulatory
analysis
least
fda
initiates
pma
process
underlying
device
new
device
substantially
equivalent
notification
process
means
comparable
pma
process
contrast
hours
necessary
complete
pma
review
review
completed
average
hours
see
hearings
one
commentator
noted
attraction
substantial
equivalence
manufacturers
clear
section
notification
requires
little
information
rarely
elicits
negative
response
fda
gets
processed
quickly
adler
medical
device
amendments
step
right
direction
needs
another
step
right
direction
food
drug
cosm
see
also
kahan
food
drug
cosm
congress
anticipated
fda
complete
pma
process
class
iii
devices
relatively
swiftly
substantial
investment
time
energy
necessary
resolution
pma
application
ever
increasing
numbers
medical
devices
internal
administrative
resource
difficulties
fda
simply
keep
rigorous
pma
process
result
premarket
notification
process
became
means
new
medical
devices
including
class
iii
devices
approved
market
instance
house
report
concluded
nearly
approximately
class
iii
devices
introduced
market
since
admitted
substantial
equivalents
without
pma
review
see
medical
device
regulation
fda
neglected
child
committee
print
compiled
subcommittee
oversight
investigations
house
committee
energy
commerce
comm
print
lopsidedness
apparently
evened
despite
increasing
effort
fda
consider
safety
efficacy
substantially
equivalent
devices
house
reported
new
class
iii
devices
introduced
market
process
without
pma
review
see
also
kessler
pape
sundwall
federal
regulation
medical
devices
new
england
med
notifications
filed
pma
application
average
fda
response
notification
one
fifth
response
time
pma
many
medical
device
manufacturers
petitioner
medtronic
took
advantage
expedited
process
october
notified
fda
intended
market
model
pacemaker
lead
device
substantially
equivalent
devices
already
market
lead
portion
pacemaker
transmits
heartbeat
steadying
electrical
signal
pulse
generator
heart
november
fda
found
model
substantially
equivalent
devices
introduced
interstate
commerce
prior
effective
date
act
advised
medtronic
therefore
market
device
subject
general
control
provisions
act
found
code
federal
regulations
see
respondent
memorandum
support
motion
summary
judgment
md
exh
exh
declaration
charles
swanson
hereinafter
fda
substantial
equivalence
letter
agency
emphasized
however
determination
construed
endorsement
pacemaker
lead
safety
ibid
cross
petitioner
lora
lohr
dependent
pacemaker
technology
proper
functioning
heart
implanted
medtronic
pacemaker
equipped
one
company
model
pacemaker
leads
december
pacemaker
failed
allegedly
resulting
complete
heart
block
required
emergency
surgery
according
physician
defect
lead
likely
cause
failure
lohr
husband
filed
action
florida
state
complaint
contained
negligence
count
strict
liability
count
negligence
count
alleged
breach
medtronic
duty
use
reasonable
care
design
manufacture
assembly
sale
subject
pacemaker
several
respects
including
use
defective
materials
lead
failure
warn
properly
instruct
plaintiff
physicians
tendency
pacemaker
fail
despite
knowledge
earlier
failures
complaint
strict
liability
count
alleged
device
defective
condition
unreasonably
dangerous
foreseeable
users
time
sale
third
count
alleging
breach
warranty
dismissed
failure
state
claim
florida
law
medtronic
removed
case
federal
district
filed
motion
summary
judgment
arguing
negligence
strict
liability
claims
section
core
dispute
parties
case
provides
state
local
requirements
respecting
devices
general
rule
except
provided
subsection
section
state
political
subdivision
state
may
establish
continue
effect
respect
device
intended
human
use
requirement
different
addition
requirement
applicable
chapter
device
relates
safety
effectiveness
device
matter
included
requirement
applicable
device
chapter
district
initially
denied
medtronic
motion
finding
nothing
statute
support
company
argument
mda
entirely
exempted
liability
manufacturer
allegedly
violated
fda
regulations
see
app
pet
cert
long
decision
however
appeals
eleventh
circuit
concluded
required
least
common
law
claims
brought
manufacturer
medical
device
see
duncan
iolab
reconsidering
ruling
light
duncan
district
reversed
earlier
decision
dismissed
lohrs
entire
complaint
appeals
reversed
part
affirmed
part
rejecting
lohrs
broadest
submission
first
decided
common
law
actions
state
requirements
within
meaning
next
held
avoided
merely
alleging
negligence
flowed
violation
federal
standards
concluding
term
requirements
unclear
sought
guidance
fda
regulations
regarding
regulations
provide
state
requirement
unless
fda
established
specific
requirements
applicable
particular
device
citing
cfr
regulations
concluded
necessary
federal
regulation
specifically
deal
pacemakers
federal
requirement
way
restricted
nature
particular
process
procedure
device
completely
open
ended
specific
device
issue
subject
requirements
approach
concluded
lohrs
negligent
design
claims
rejected
medtronic
argument
fda
finding
substantial
equivalence
significance
respect
pacemaker
safety
fda
continued
surveillance
device
constituted
federal
requirement
design
maintained
hand
concluded
negligent
manufacturing
failure
warn
claims
fda
general
good
manufacturing
practices
regulations
establish
general
requirements
steps
every
device
manufacture
see
cfr
fda
labeling
regulations
require
devices
bear
various
warnings
see
cfr
made
parallel
disposition
strict
liability
claims
holding
insofar
plaintiffs
alleged
unreasonably
dangerous
design
revive
negligent
manufacturing
failure
warn
claims
strict
liability
theory
medtronic
filed
petition
certiorari
seeking
review
appeals
decision
insofar
affirmed
district
lohrs
filed
cross
petition
seeking
review
judgment
insofar
upheld
defense
courts
appeals
divided
extent
state
common
law
claims
mda
granted
petitions
cipollone
liggett
group
presented
task
interpreting
statutory
provision
expressly
state
law
language
means
need
go
beyond
language
determine
whether
congress
intended
mda
least
state
law
see
must
nonetheless
identify
domain
expressly
language
ibid
although
analysis
scope
statute
must
begin
text
see
gade
national
solid
wastes
management
kennedy
concurring
part
concurring
judgment
interpretation
language
occur
contextual
vacuum
rather
interpretation
informed
two
presumptions
nature
see
ibid
first
independent
sovereigns
federal
system
long
presumed
congress
cavalierly
state
law
causes
action
cases
particularly
congress
legislated
field
traditionally
occupied
rice
santa
fe
elevator
start
assumption
historic
police
powers
superseded
federal
act
unless
clear
manifest
purpose
congress
hillsborough
cf
fort
halifax
packing
coyne
although
dissenting
justices
argued
assumption
apply
question
whether
congress
intended
opposed
questions
concerning
scope
intended
invalidation
state
law
see
cipollone
scalia
concurring
judgment
part
dissenting
part
used
presumption
state
police
power
regulations
support
narrow
interpretation
express
command
cipollone
approach
consistent
federalism
concerns
historic
primacy
state
regulation
matters
health
safety
second
analysis
scope
statute
guided
oft
repeated
comment
initially
made
retail
clerks
schermerhorn
purpose
congress
ultimate
touchstone
every
case
see
cipollone
gade
malone
white
motor
result
understanding
scope
statute
must
rest
primarily
fair
understanding
congressional
purpose
cipollone
opinion
stevens
congress
intent
course
primarily
discerned
language
statute
statutory
framework
surrounding
gade
kennedy
concurring
part
concurring
judgment
also
relevant
however
structure
purpose
statute
whole
opinion
revealed
text
reviewing
reasoned
understanding
way
congress
intended
statute
surrounding
regulatory
scheme
affect
business
consumers
law
considerations
mind
turn
first
consideration
petitioner
medtronic
claim
appeals
found
entire
action
merits
lohrs
cross
petition
petition
medtronic
argues
appeals
erred
concluding
lohrs
claims
alleging
negligent
design
section
provides
state
political
subdivision
state
may
establish
continue
effect
respect
device
intended
human
use
requirement
different
addition
requirement
applicable
chapter
device
relates
safety
effectiveness
device
matter
included
requirement
applicable
device
chapter
medtronic
suggests
common
law
cause
action
requirement
alters
incentives
imposes
duties
different
addition
generic
federal
standards
fda
promulgated
response
mandates
mda
essence
company
argues
plain
language
statute
common
law
claims
brought
injured
plaintiff
manufacturer
medical
devices
medtronic
argument
unpersuasive
implausible
medtronic
view
statute
congress
effectively
precluded
state
courts
affording
state
consumers
protection
injuries
resulting
defective
medical
device
moreover
explicit
private
cause
action
manufacturers
contained
mda
suggestion
act
created
implied
private
right
action
congress
barred
relief
persons
injured
defective
medical
devices
medtronic
construction
therefore
perverse
effect
granting
complete
immunity
design
defect
liability
entire
industry
judgment
congress
needed
stringent
regulation
order
provide
safety
effectiveness
medical
devices
intended
human
use
stat
preamble
act
say
least
difficult
believe
congress
without
comment
remove
means
judicial
recourse
injured
illegal
conduct
silkwood
kerr
mcgee
take
language
much
plainer
text
convince
us
congress
intended
result
furthermore
congress
intended
preclude
common
law
causes
action
chose
singularly
odd
word
statute
achieved
identical
result
instance
precluded
remedy
state
law
relating
medical
devices
requirement
appears
presume
state
imposing
specific
duty
upon
manufacturer
although
prior
occasions
concluded
statute
certain
state
requirements
also
common
law
damages
claims
see
cipollone
opinion
stevens
statute
sweep
nearly
broadly
medtronic
us
believe
statute
statute
cipollone
targeted
limited
set
state
requirements
based
smoking
health
limited
subset
possible
applications
requirements
involving
advertising
promotion
cigarettes
packages
labeled
conformity
provisions
federal
statute
see
context
giving
term
requirement
widest
reasonable
meaning
nearly
scope
effect
potential
remedies
medtronic
broad
reading
term
case
cipollone
held
petitioner
case
able
maintain
common
law
actions
using
theories
case
run
afoul
statute
see
however
medtronic
sweeping
interpretation
statute
require
far
greater
interference
state
legal
remedies
producing
serious
intrusion
state
sovereignty
simultaneously
wiping
possibility
remedy
lohrs
alleged
injuries
given
ambiguities
statute
scope
preclusion
occur
otherwise
accept
medtronic
argument
using
congress
clearly
signaled
intent
deprive
role
protecting
consumers
dangers
inherent
many
medical
devices
differences
statute
one
cipollone
convince
us
congress
enacted
primarily
concerned
problem
specific
conflicting
state
statutes
regulations
rather
general
duties
enforced
common
law
actions
unlike
statute
issue
cipollone
refers
requirements
many
times
throughout
text
instance
word
linked
language
suggesting
focus
device
specific
enactments
positive
law
legislative
administrative
bodies
application
general
rules
common
law
judges
juries
instance
subsections
statute
also
refer
requirements
requirements
refer
statutory
regulatory
law
exists
pursuant
mda
suggesting
requirements
established
continued
also
refer
primarily
positive
enactments
state
law
moreover
subsection
fda
given
authority
exclude
certain
requirements
scope
statute
limited
number
exemptions
fda
granted
none
even
remotely
resemble
common
law
claims
examination
basic
purpose
legislation
well
history
entirely
supports
rejection
medtronic
extreme
position
mda
enacted
provide
safety
effectiveness
medical
devices
intended
human
use
stat
medtronic
asserts
act
also
intended
however
innovations
device
technology
stifled
unnecessary
restrictions
brief
petitioners
citing
interest
extended
common
law
claims
act
certainly
reflects
concerns
legislative
history
indicates
fears
regarding
regulatory
burdens
related
risk
additional
federal
state
regulation
rather
danger
preexisting
duties
common
law
see
cong
rec
mar
statement
collins
opposing
redundant
burdensome
federal
requirements
discussing
efforts
taken
mda
protect
small
businesses
additional
requirements
act
indeed
nowhere
materials
relating
act
history
discovered
reference
fear
product
liability
actions
hamper
development
medical
devices
extent
congress
concerned
protecting
industry
intent
manifested
primarily
fewer
substantive
requirements
act
provision
furthermore
concern
far
outweighed
concerns
primary
issue
motivating
mda
enactment
safety
use
medical
devices
legislative
history
also
confirms
understanding
simply
intended
let
alone
general
common
law
duties
enforced
damages
actions
best
knowledge
nothing
hearings
committee
reports
debates
suggesting
proponent
legislation
intended
sweeping
traditional
common
law
remedies
manufacturers
distributors
defective
devices
congress
intended
result
failure
even
hint
spectacularly
odd
particularly
since
members
houses
acutely
aware
ongoing
product
liability
litigation
along
less
precise
language
silence
surely
indicates
least
common
law
claims
medical
device
manufacturers
may
maintained
enactment
mda
medtronic
asserts
several
specific
reasons
even
common
law
claims
least
lohrs
claims
case
contrast
lohrs
argue
entire
complaint
survive
reasonable
evaluation
scope
first
lohrs
claim
appeals
correctly
held
negligent
design
claims
premarket
notification
process
imposes
requirement
design
medtronic
pacemaker
second
suggest
even
fda
general
rules
regulating
manufacturing
practices
labeling
requirements
different
state
requirements
state
rules
merely
duplicate
federal
requirements
finally
argue
state
general
rules
imposing
common
law
duties
upon
medtronic
impose
requirement
respect
device
conflict
fda
general
rules
relating
manufacturing
labeling
therefore
design
claim
appeals
concluded
lohrs
defective
design
claims
requirements
company
comply
sufficiently
concrete
constitute
federal
requirement
medtronic
counters
pointing
fda
determination
model
substantially
equivalent
earlier
device
well
agency
continuing
authority
exclude
device
market
design
changed
factors
medtronic
argues
amount
specific
federally
enforceable
design
requirement
affected
state
law
pressures
imposed
manufacturers
subject
product
liability
suits
company
defense
exaggerates
importance
process
fda
letter
company
regarding
pacemaker
substantial
equivalence
grandfathered
device
noted
process
focused
equivalence
safety
result
substantial
equivalence
determinations
provide
little
protection
public
determinations
simply
compare
device
device
ascertain
whether
later
device
dangerous
less
effective
earlier
device
earlier
device
poses
severe
risk
ineffective
later
device
may
also
risky
ineffective
adler
food
drug
cosm
design
model
design
substantially
equivalent
devices
never
formally
reviewed
mda
safety
efficacy
fda
stressed
basic
conclusion
letter
medtronic
finding
lead
substantially
equivalent
devices
already
market
letter
required
medtronic
comply
general
standards
lowest
level
protection
applicable
medical
devices
including
listing
devices
good
manufacturing
practices
labeling
misbranding
adulteration
provisions
act
explicitly
warned
medtronic
letter
way
denote
official
fda
approval
device
ny
representation
creates
impression
official
approval
device
compliance
premarket
notification
regulations
misleading
constitutes
misbranding
fda
substantial
equivalence
letter
thus
even
though
fda
may
well
examine
applications
class
iii
devices
examines
entire
medical
device
industry
concern
safety
effectiveness
device
see
brief
petitioner
pp
require
medtronics
pacemaker
take
particular
form
particular
reason
agency
simply
allowed
pacemaker
device
substantially
equivalent
one
existed
marketed
without
running
gauntlet
pma
process
providing
exemption
pma
review
congress
intended
merely
give
manufacturers
freedom
compete
limited
degree
terms
manufacturers
medical
devices
existed
prior
suggestion
either
statutory
scheme
legislative
history
exemption
process
intended
anything
maintain
status
quo
respect
marketing
existing
medical
devices
substantial
equivalents
status
quo
included
possibility
manufacturer
device
defend
state
law
claims
negligent
design
given
background
behind
substantial
equivalence
exemption
fact
purpose
congress
ultimate
touchstone
every
case
internal
quotation
marks
citations
omitted
presumption
appeals
properly
concluded
substantial
equivalence
provision
lohrs
design
claims
identity
requirements
claims
lohrs
next
suggest
even
requirements
exist
respect
manufacturing
labeling
pacemaker
even
also
consider
state
law
impose
requirement
act
state
requirement
unless
different
addition
federal
requirement
although
precise
contours
theory
recovery
yet
defined
issue
decided
basis
pleadings
clear
lohrs
allegations
may
include
claims
medtronic
extent
exist
violated
fda
regulations
least
claims
suggest
maintained
without
agree
nothing
denies
florida
right
provide
traditional
damages
remedy
violations
common
law
duties
duties
parallel
federal
requirements
even
may
necessary
matter
florida
law
prove
violations
result
negligent
conduct
created
unreasonable
hazard
users
product
additional
elements
state
law
cause
action
make
state
requirements
narrower
broader
federal
requirement
narrower
requirement
might
different
federal
rules
literal
sense
difference
surely
provide
strange
reason
finding
state
rule
insofar
duplicates
federal
rule
presence
damages
remedy
amount
additional
different
requirement
necessary
statute
rather
merely
provides
another
reason
manufacturers
comply
identical
existing
requirements
federal
law
fda
regulations
interpreting
scope
effect
support
lohrs
view
interpretation
statute
substantially
informed
regulations
different
views
expressed
courts
appeals
regarding
appropriate
scope
federal
demonstrate
language
section
entirely
clear
addition
congress
given
fda
unique
role
determining
scope
effect
unlike
statute
construed
cipollone
instance
mda
arise
directly
result
enactment
statute
rather
cases
state
law
extent
fda
promulgated
relevant
federal
requirement
fda
federal
agency
congress
delegated
authority
implement
provisions
act
agency
uniquely
qualified
determine
whether
particular
form
state
law
stands
obstacle
accomplishment
execution
full
purposes
objectives
congress
hines
davidowitz
therefore
whether
example
congress
explicitly
delegated
fda
authority
exempt
state
regulations
effect
mda
authority
necessarily
requires
fda
assess
effect
act
regulations
state
laws
see
fda
regulations
implementing
grant
authority
establish
process
individuals
may
request
advisory
opinion
fda
regarding
whether
particular
state
requirement
statute
see
cfr
ambiguity
statute
congressional
grant
authority
agency
matter
contained
within
provide
sound
basis
post
giving
substantial
weight
agency
view
statute
see
chevron
natural
resources
defense
council
hillsborough
considering
fda
understanding
effect
regulations
dispositive
regulations
promulgated
fda
expressly
support
conclusion
preempt
state
local
requirements
equal
substantially
identical
requirements
imposed
act
cfr
see
also
early
stage
litigation
reason
appeals
preclude
altogether
lohrs
manufacturing
labeling
claims
extent
rest
claims
medtronic
negligently
failed
comply
duties
equal
substantially
identical
requirements
imposed
federal
law
manufacturing
labeling
claims
finally
lohrs
suggest
respect
manufacturing
labeling
claims
appeals
rejected
medtronic
defense
full
appeals
believed
claims
interfere
consistent
application
general
federal
regulations
governing
labeling
manufacture
medical
devices
therefore
concluded
claims
altogether
requirements
identified
appeals
include
labeling
regulations
require
manufacturers
every
medical
device
limited
exceptions
include
device
label
containing
information
use
relevant
hazards
contraindications
side
effects
precautions
cfr
similarly
manufacturers
required
comply
good
manufacturing
practices
gmp
set
forth
sections
less
pages
code
federal
regulations
certain
circumstances
appeals
recognized
fda
enforce
general
requirements
manufacturers
violate
see
admitting
requirements
exist
lohrs
suggest
general
nature
simply
claims
alleging
manufacturer
failed
comply
duties
state
common
law
support
claim
note
expressly
federal
requirement
must
applicable
device
question
effect
labeling
manufacturing
requirements
applicable
host
different
devices
argue
satisfy
condition
argue
state
requirements
respect
device
may
requirement
relates
safety
effectiveness
device
matter
included
requirement
applicable
device
section
mandates
conflict
specific
state
requirement
federal
requirement
applicable
device
lohrs
theory
supported
fda
regulations
provide
state
requirements
fda
established
specific
counterpart
regulations
specific
requirements
applicable
particular
device
cfr
note
statute
intended
state
local
requirements
general
applicability
purpose
requirement
relates
either
products
addition
devices
unfair
trade
practices
requirements
limited
devices
regulations
specifically
provide
examples
permissible
general
requirements
general
electrical
codes
uniform
commercial
code
warranty
fitness
see
ibid
regulations
even
go
far
state
generally
preempt
state
local
requirement
prohibiting
manufacture
adulterated
misbranded
devices
unless
prohibition
effect
establishing
substantive
requirement
specific
device
ii
furthermore
authority
grant
exemptions
effect
fda
never
granted
best
knowledge
even
asked
consider
granting
exemption
state
law
general
applicability
existing
exemptions
apply
excruciatingly
specific
state
requirements
regarding
sale
hearing
aids
see
although
believe
statutory
regulatory
language
necessarily
precludes
general
federal
requirements
ever
state
requirements
general
state
requirements
ever
see
part
vi
infra
impossible
ignore
overarching
concern
occur
particular
state
requirement
threatens
interfere
specific
federal
interest
state
requirements
must
respect
medical
devices
different
addition
federal
requirements
state
requirements
must
also
relate
safety
effectiveness
device
matter
included
requirement
applicable
device
regulations
provide
state
requirements
general
applicability
except
effect
establishing
substantive
requirement
specific
device
moreover
federal
requirements
must
applicable
device
question
according
regulations
state
law
specific
counterpart
regulations
specific
particular
device
statute
regulations
therefore
require
careful
comparison
allegedly
federal
requirement
allegedly
state
requirement
determine
whether
fall
within
intended
scope
statute
regulations
comparison
mandates
conclusion
lohrs
common
law
claims
federal
labeling
manufacturing
requirements
generality
requirements
make
quite
unlike
case
federal
government
weighed
competing
interests
relevant
particular
requirement
question
reached
unambiguous
conclusion
competing
considerations
resolved
particular
case
set
cases
implemented
conclusion
via
specific
mandate
manufacturers
producers
rather
federal
requirements
reflect
important
entirely
generic
concerns
device
regulation
generally
sort
concerns
regarding
specific
device
field
device
regulation
statute
regulations
designed
protect
potentially
contradictory
state
requirements
similarly
general
state
common
law
requirements
case
specifically
developed
respect
medical
devices
accordingly
kinds
requirements
congress
fda
feared
impede
ability
federal
regulators
implement
enforce
specific
federal
requirements
legal
duty
predicate
lohrs
negligent
manufacturing
claim
general
duty
every
manufacturer
use
due
care
avoid
foreseeable
dangers
products
similarly
predicate
failure
warn
claim
general
duty
inform
users
purchasers
potentially
dangerous
items
risks
involved
use
general
obligations
threat
federal
requirements
state
law
duty
comply
local
fire
prevention
regulations
zoning
codes
use
due
care
training
supervision
workforce
state
requirements
therefore
escape
source
duty
judge
made
common
law
rule
rather
generality
leaves
outside
category
requirements
envisioned
respect
specific
devices
pacemakers
result
none
lohrs
claims
based
allegedly
defective
manufacturing
labeling
mda
cross
petition
lohrs
present
final
argument
suggesting
common
law
duties
never
requirements
within
meaning
statute
therefore
never
common
law
actions
lohrs
point
holding
cipollone
dispositive
issue
part
iv
supra
suggests
significant
textual
historical
differences
cipollone
statute
meaning
words
must
always
informed
environment
within
situated
think
issue
resolved
fda
regulation
suggesting
applicable
requirements
force
effect
law
established
decision
cfr
reference
appears
intended
refer
decisions
construing
state
statutes
regulations
see
fed
reg
june
brief
petitioners
nevertheless
respond
directly
argument
two
reasons
first
since
none
lohrs
claims
case
need
resolve
hypothetical
cases
may
arise
future
second
given
critical
importance
device
specificity
fda
construction
apparent
common
law
duties
statute
rare
indeed
hearing
common
law
cause
action
issue
decree
effect
establishing
substantive
requirement
specific
device
cfr
ii
case
arises
see
need
determine
whether
statute
explicitly
claim
even
issue
may
need
resolved
claim
also
conflict
analysis
see
freightliner
myrick
slip
accordingly
judgment
appeals
reversed
insofar
held
claims
affirmed
insofar
rejected
defense
case
remanded
proceedings
ordered
notes
fda
yet
initiated
suggested
initiation
pma
process
pacemakers
grandfathered
devices
see
fed
reg
pursuant
safe
medical
devices
act
stat
calling
submission
information
february
may
lead
fda
reclassify
initiate
pma
process
time
future
implantable
pacemaker
pulse
generators
lead
adapters
congress
enacted
amendments
mda
designed
reduce
fda
reliance
process
continuing
ensure
particularly
risky
devices
received
full
pma
review
see
safe
medical
devices
act
subsection
statute
authorizes
fda
grant
exemptions
state
requirements
otherwise
subsection
section
provides
exempt
requirements
upon
application
state
political
subdivision
thereof
secretary
may
regulation
promulgated
notice
opportunity
oral
hearing
exempt
subsection
section
conditions
may
prescribed
regulation
requirement
state
political
subdivision
applicable
device
intended
human
use
requirement
stringent
requirement
chapter
applicable
device
exemption
effect
subsection
requirement
required
compelling
local
conditions
compliance
requirement
cause
device
violation
applicable
requirement
chapter
carry
grant
authority
fda
issued
regulations
statute
construe
scope
address
instances
fda
grant
exemptions
effect
see
cfr
infra
note
although
fda
exercises
authority
act
gives
authority
directly
secretary
health
human
services
subsequently
delegated
authority
fda
see
secretary
may
exempt
state
requirements
secretary
defined
secretary
health
human
services
fdca
secretary
vested
authority
promulgate
regulations
efficient
enforcement
act
see
english
mentor
process
creates
requirements
feldt
mentor
process
create
requirements
michael
shiley
claim
alleging
violation
federal
requirement
case
claim
alleging
violation
federal
requirement
may
process
may
create
requirements
common
law
claims
covered
kennedy
collagen
common
law
claims
covered
fda
authority
require
manufacturers
recall
replace
refund
defective
devices
little
use
injured
plaintiffs
since
indication
right
available
private
parties
remedy
extend
recovery
compensatory
damages
authority
rarely
invoked
see
adler
medical
device
amendments
step
right
direction
needs
another
step
right
direction
food
drug
cosm
actually
two
statutes
issue
first
enacted
provided
statement
relating
smoking
health
shall
required
cigarette
package
cigarette
advertising
see
cipollone
liggett
group
provision
concluded
petitioner
common
law
claims
congress
superseded
statute
part
public
health
cigarette
smoking
act
provided
requirement
prohibition
based
smoking
health
shall
imposed
state
law
respect
advertising
promotion
cigarettes
packages
labeled
conformity
provisions
act
bulk
cipollone
analysis
involved
later
statute
unless
otherwise
stated
statute
refer
subsequent
references
statute
cipollone
unlike
effect
statute
cipollone
dependent
issuance
agency
regulations
territory
exclusively
occupied
federal
law
defined
text
statute
text
specified
precise
warning
smokers
congress
deemed
necessary
sufficient
mda
specifics
exist
fda
provides
see
also
infra
reliance
fda
interpretation
warranted
inter
alia
fda
role
administration
moreover
statute
cipollone
clearly
intended
broader
effect
predecessor
see
text
statute
quoted
supra
exemptions
cfr
exemptions
state
statutes
regulations
regarding
sale
hearing
aids
special
statutory
exemptions
example
permit
fda
various
oversight
provisions
allow
investigative
experimental
devices
used
commerce
without
either
pma
review
substantial
equivalence
see
cfr
pt
moreover
existence
statute
demonstrates
concern
competing
state
requirements
may
unduly
interfere
market
medical
devices
furthermore
congress
intended
mda
work
dramatic
change
availability
state
law
remedies
one
expect
reference
change
extensive
contemporary
reviews
legislation
able
find
reference
see
lesparre
industry
spokesman
comments
medical
device
amendments
hospitals
levine
device
failure
plaintiff
lawyer
proceedings
second
annual
conference
medical
device
regulation
medical
device
amendments
hearings
subcommittee
health
environment
house
committee
interstate
foreign
commerce
ser
statement
anita
johnson
public
citizen
health
research
group
arguing
provision
included
making
mention
common
law
specifically
discussing
positive
california
enactment
regarding
safety
intrauterine
contraceptive
devices
medical
devices
equipment
liability
avoidance
frost
sullivan
pub
june
comprehensive
volume
page
review
published
medical
device
product
liability
cases
suggesting
nowhere
mda
mooted
even
altered
longstanding
ability
plaintiffs
seek
receive
damages
awards
state
law
fda
commissioner
put
provision
law
procompetition
mechanism
permits
firms
make
quickly
market
versions
devices
congress
apparently
believed
firm
whose
device
happened
market
enactment
amendments
never
subject
preclearance
fda
enjoy
lengthy
monopoly
expense
firms
ultimately
consumer
fda
oversight
medical
devices
hearing
subcommittee
oversight
investigations
house
committee
energy
commerce
see
also
kahan
premarket
approval
versus
premarket
notification
different
routes
market
food
drug
cosm
kessler
pape
sundwall
federal
regulation
medical
devices
new
england
med
see
supra
also
note
agency
permits
manufacturers
devices
received
premarket
approval
make
certain
labeling
quality
control
manufacturing
changes
enhance
safety
device
safety
use
device
without
prior
fda
approval
see
cfr
gmp
include
duty
institute
quality
assurance
program
adequate
organizational
structure
ensure
personnel
contact
device
clean
healthy
suitably
attired
matters
relevant
device
safety
buildings
environmental
controls
equipment
quality
adequate
produce
safe
product
see
fda
narrow
understanding
scope
obvious
full
text
regulation
provides
relevant
part
state
local
requirements
preempted
food
drug
administration
established
specific
counterpart
regulations
specific
requirements
applicable
particular
device
act
thereby
making
existing
divergent
state
local
requirements
applicable
device
different
addition
specific
food
drug
administration
requirements
state
local
requirements
affect
devices
preempted
section
act
requirements
applicable
device
within
meaning
section
act
following
examples
state
local
requirements
regarded
preempted
section
act
section
preempt
state
local
requirements
general
applicability
purpose
requirement
relates
either
products
addition
devices
requirements
general
electrical
codes
uniform
commercial
code
warranty
fitness
unfair
trade
practices
requirements
limited
devices
section
preempt
state
local
requirements
equal
substantially
identical
requirements
imposed
act
section
preempt
state
local
requirements
respecting
general
enforcement
requirements
state
inspection
permitted
factory
records
concerning
devices
ii
generally
section
preempt
state
local
requirement
prohibiting
manufacture
adulterated
misbranded
devices
however
prohibition
effect
establishing
substantive
requirement
specific
device
specific
labeling
requirement
prohibition
may
preempted
cfr
plurality
concluded
cipollone
similar
analysis
required
public
health
cigarette
smoking
act
act
requirements
prohibitions
based
smoking
health
imposed
state
law
respect
advertising
promotion
cigarettes
packages
labeled
conformity
act
held
petitioner
fraudulent
misrepresentation
claims
including
based
allegedly
false
statements
made
advertisements
predicated
duty
based
smoking
health
rather
general
obligation
duty
deceive
general
common
law
duty
make
fraudulent
statements
within
specific
category
requirements
prohibitions
based
smoking
health
imposed
state
law
respect
advertising
promotion
cigarettes
statute
anything
language
mda
statute
counterpart
regulations
require
even
searching
inquiry
relationship
federal
requirement
state
requirement
issue
true
statute
cipollone