Operating instructions
1807.81
act,
or
beoa.wIe
the
Oommillldo'Dllr
baa
found,
un4er
HCtton
IWI(a'X4)
of
tile
act,
tha.t
INCh 1'eI1IItr&tlon
18
not
neo-
eaearr
for
the
proteotion
of
tile
publ10
heaJ.th:
(a)
A
manufacturer
of
raw
matertaJa
or
OO!D,JlODeD.ta
to
be
1UMI41ll
tile
DIaDU-
facture
or
UlMlmbly
of
a
device
who
woUld
otllerwtee
not
be
requUed
to
re-
lIter
1lDder
the
pro'9ia10D.l
of
th1a
part.
(b)
A
DINl1I.t'aot;a.
of
devioee
to
be
uae4
1I01el;v
for
veter1Daz7
parpoeea.
(0)
A manul.lr.ot1U'el.'
of
..,Del'8l JIIB'-
poee
artlol.
INCh
...
ohem1oaJ.l'tIa8'8Dta
or
laboratorr
equ1P1D8Dt
whale
WMIII
are
pmeraJJ;r
1I:nowu
by
JI81"IOD.I
tr&1Ded.
lD
the.tr
uae
aad
w)doh
an
not
labeled
or
promoted
for
lD.Id:I.oaJ.
....
(d)
LiC!llUed
InOtitioneN.
lDoladiD&'
Pba101ane.
dentlltta,
UI4
optom.etzJat;a,
who
manafaoture
or
otberw1ae
alter
de-
vicell
lIolely
for
'DIe
in
theb'
llI'IICt1oe.
(e)
Pbarmao:l..
lIU.l'Ir1oaJ.
1lUP.Pb"
oat-
leta.
or
otller
atmU.a.r
ret&U
8IItabl1all-
menta
maJr::IDa'
tIDal
delivery
or
Sale
to
the
Illttmate
lIIIer.
Th1a
azemption
a1Io
appUee
to
a
pharmac,p'
or
other
IIImUar
retall utabl.Jahment
tha.t
IIIU'ClwIeII a
devioe
for
IIUbllequeat
41atrlbutlon
under
ita
own
Dame.
e..c
••
a properb"
la-
beled
bea.lth
a14
noh
..
a.n
elaIt10
baD-
4aIW
or
crutch,
lDcUaatlDlr
"41atrlbute4
b7"
or
"DI&D11faotm:'e4
for"
fonOWed b7
the
name
of
the
pba.r.mao;v.
(f)
PerIIODa
who
DI&D'I1faotnre,
pre_
p&re,
PI'OJIIoIILte.
compoUlld.
or
PI'OO8IIII
dev1cea
IIOlel:v
for
WIe
lD
'NIIeiI.rOh.
Macbtnr.
or
ana.lJ'sl1l
aad
do
not
intro-
d1Kl8
such
dev1cee
lDto
oommero1&l
d1II--
trlbutton.
<&')
[ReeervedJ
(h)
Ca.nierI
by
reason
of
their
""'"
oe1pt,
a&rrIa8e.
holdlDtr
or
delivery
of
4evioee
lD
the
ua1l&l
oourae
of
bUld.D.lla
...
C&l'Z'1erII.
(1)
PerIIOD.I
who
418pmae
dev10ea
to
the
ulttmate
CODliumer
or
whose
major
reapc:matb1l1ty
18
to
.reDder a
Mrv10e
n808lllll.r;v
to
provide
the
OOIllltll'l28r
(1.e
••
patient,
lIbn101an,.
la.7maD.
eta.)
With a
dev10e
or
tile
beneAta
to
be
derlved
from
the
WIll
of
a
device;
for
aample,
a
lIear1Dr
a14
d1apemer.
optlo1an,.
o11Dia&1
laborat.or;v.
uaembler
of
d1acnOlltio
.1:-
ra.:v
antema.
aad
PI\lIIOll.D.Il
from
a
hoe-
Plt&J..
ollDio.
denta.l
labor&t.ar:v.
orthotic
or
protIthetto
retall
facWty,
whOle
IIl"1m&r:v
ftIQODatbWty
to
the
ul-
ttmate
00D.I1:I.mer
18
to
diapaDBe
or
pro-
21
CR
OL
I *,1-951d11on)
vide a
IMII'v1ce
tbroqh
tile
11118
or
a pre..
vioaalJ'
manufactured
devloe.
[G
lI'B
...
Aq
...
1""
..
IUI1IIIIdII4
at
118
lI'B
-.
8QII. 1.
18IIJ
Subpart
E-Prernark.t
NotIIIcaIIon
Proc:ecI\nI
._.81
.....
~
IIO*HIeMtoa
.............
NqIdrecL
(a)
lIIlroapt
..
prov14ed
lD
~
(b)
or
th1a
IIMItloD,
e&Ch
perIIOD
who
ta
req1'dred
to
retiater
h1a eata,:bl1abment
JIUI.'lIQImt
to
,IOUO
JDUIIt
n.bm1t a pre..
l!IaE'1I:et; not1flo&t1on au'bmHBI.on
to
tile
Poo4
UI4
Dna' Adm1D:Iatir&tlon
at
le&It
110
dan
before
he
proJIQIIIIS
to
ber1D
the
lDt.rod.llOt1on
or
4e11ver;v
for
lDt.rod.uo-
tion
lDto
lDteratate
commerce
fbr
com-
m«cf&l
c11atr.lbutton
or
a 4ev1oe, lD-
tended
for
h1Ima.D
ue
wJI10h
meets 8D7
of
the fonow1JJ8' orltert&:
(1)
The
device
ill
beiDr
lDtr:04vced
lDto
oommero1al diIItrlbQt10D
for
tile
ant
time;
thlLt
111.
the
device
111
not
or
the
IIIIIlIe
t:vPe
...
or
ill
DOt
1IlbetaIl-
ttall:v
8Qll11'11leat
to,.
(1) a 4ev1ce
lD
oommercial 41atrlbut1cm
before
Mq
.,
um.
or
(ll)
a
device
int.rod.a0e4
for
oommeroJal
41atr1bQt1oD
after
:atq
as.
um.
that
lIaa aub8equenta:v
been
reol&l-
IIUI.ecllDto
oJ&a
I
or
II.
(2)
The
device
ill
beiDr
lDtnIdu0e4
lDto
oommerct&l 41atrtbut1on
for
the
flNt
time
by
a
penon
reqU1recl
to
J'8f-
tater, whether
or
Dot
the
d.ev1oe
meete
the
orlter!a
lD
JIIIl'&I1'.NIIh
(a)(1)
of
thiII
IIMIt1oD.
(8)
The
dev10e
18
one
that
tile
penon
olUnlDt1;v lIaa
lD
oommercIal
diatrlbu-
taon
or
18
nlDt.rod.uoiq
lDto oommer-
o1al c11atr.lbution,
but
that
ill
aboat
to
be
lIIP1flocta:v
clI.I.DP4
or
modified
lD
dea1p,
oompoD8Dta,
method
of
DIAoDU-
f'.IIctiIu:8.
or
lDten4ed
DIIe. The
tonoW1Dg
COIUStitute
1iID1110000t
o1I&zIaIIe
or
madl-
fioat1oDB
that
requ:lre a
premarlI:et
DO-
Wlcatlon:
(I) A
olIa.IICe
or
modifloatton
lD
the
devioe
thlLt
OOtild
mpUIOUIIi1:J' &Ifeot
the
II&fety
or
ettecti.,....
of
the
de-
vice
.......
a
mDdfloaDt
oha.'IIre
or
modi-
Ao&t1oD
lD
deII1rn, matert&1. ohem1oal
oompoaltlon,
enerr:v
IODrOe.
or
ma:I1U-
fact.1u'1Dr
p:ooe8L
(11)
A
ma.Jor
~
or
modUlcatlon
lD
the
1DtaD4e4
11118
of
tile
4ev1oe.
(b)
A Jll('tllll6rll:at
DOt1.f1oat1on
under
th1a enbJlN't
18
DOt
l"8IlIl1.re4
for
a device
Food
and
DIug
~
HHS
for
which a
~t
approval
appli-
cation
under
MOtion 6U
or
the
aot,
or
for
wh10h
a
petition
to
reola8II1fy
11Ilder
.
IIIOt1oD
618(0(2)
of
the
act,
ill
pen4I.nr
bal'ore
the
Food.
IDCl
Drar
Ad:a:dD1atra.-
tlOD.
(c)
In
a44itlon
to
COI'DPI:J1Dr
With
the
Ntl1drameDtII
or
thiII 18ft.
0WDCn
or
operators
of
dImce
eata:bl1abme1lta
that
mruautaoture rad1atiOD-em1tttDg eleo-
trOD1o
produota.
..
deft:aed
1D
11000.8
of
th1a
olIapter.
IIluIll
00DlPl:v
with
the
""'"
lI01'tiitDIr
requ1remeDta
or
Part
1002
of
.-
thiII
..........
oh&pt;er.
""-,.......
DOtIfImI.oa.
(a)
A 4ev1ce
Ja
exempt
from
the
pre..
marll:at DOttfloation
requtrementa
of
thiII
aubl8ft
if
the
device
lDten4ed
for
1Dt.rod.act1on 1llto comm.ercI&l 41atrlbu-
tion
18
DOt
II\mIIrIJ.l:v
aV&ll&b1e
lD
ilD-
1abfld
form
for pm:chaae
and
Ia
not
or-
fered
t.hr.'oaIrh
labe11Ilr
or
84verCi11dD1r
b7
the
manufacturer.
bDporter,
or
d1a-
trlbutor
therIOt
for
oommerolal
d1a-
trlbul1on.
&rid
the
device
meeta
ODe
of
the
followlnr
CODcUt1ODB:
(1)
It
ill
lDten4e4 for
WI8
by
a
pr.tient
named
m
the
order
of
the'
pbn10jaa
or
4entlat
(or
other
apeciall;v
QUAlUled
perIOD);
or
(2)
It
18
mten4ed
801el:v
for
ue
by
a
pbplol.aD
or
4entiat
(or
Othel' speo1a1J.;v
quaUfled
penon)
&rid
ill
Dot
~
avallab1e
to.
or
I8Ml'al1:v
uae4
by.
other
l'Ib78toiaDll
or
4entlllta (or
othel'
speo1a.ll;v
quaU1led
pereona).
.
(b)
A c1fIItr1butor
who
plaoee
a
device
lDto
00IlUIlC'01a.1
41atr1but1oD
for
tile
flNt
time
under
hill
own
name
and
a
repr.okaatIr
who
plaoee
hill
own
Dam.
on
a
device
&rid
40ee
not
~
8.117
otliar
label1Ilr
or
otherw1lle
at!'eGt
tile
device
abaD:
be
eumpted
from
the
pre-
l!IaE'lI:at
DOtuloatlon
reqa1rementll
of
th1a
aubpa,rt
if:
(1)
The
4ev1oe
waa
in
oommeroI.al
4111-
trlbQtion
before
M'a:r
sa.
1lr18;
or
(2) A prema:rll:et DOtIf1oat1cm aubm1a-
mon
W&I
41e4
b7
&DOther
penon.
'_.8'l
I'IItbI:matloD
~
ba
.....
...w~
..........
lIIach premarll:et notttlc&t1on
IlUbm1a-
mon IIluIll
CODta1n
the
follow1JJ8'
lDfor-
maticm.:
(a)
The
4ev1ce
name,
inolDdlnr
both
the
tza4e
or
1'Il'OPriet&ry
Dame
UI4
the
oommon or
uual
name
or
olUlll.t1c&-
tion
Dame
of
the
device.
(b)
Th.
aetabl1ahment
rertetratlon
nnmber,
if
app11cable,
of
the
owner
or
operator
IIlibmittlDr
the
prema.rll:et
no-
tifleation
aubmllatOD.
(0)
The
olJulB
lD
wJdoh
the
device
:baa
been
put
11Ilder
MOtion
513
of
the
'aot
&Q4,
if
Imown,
ita
appropriate
pa.uel;
or,
if
tile
owner
or
operator
determines
th&t
the
device
hu
not
been clMa11led
1lJlder
I1lCh
I8Otton. a
ltatement
of
that
determ1Dation
and
the
baa1a
for
the
pel'lOD'l
deter.m1Dat1on
that
the
device
18
not
80 olUJllUle4.
(d)
Action
talI:en
by
the
persoD
re--
(lu1red
to
rerbter
to
ooDlPb'
With
the
reqn1.remeDta
or
the
act
under
I8Otlon
&14
for
pertomumce
1It&D.4.v4a.
(e)
Propoeed
labels,
labe11D.tr,
IDCl
84-
vert1aemeDtII
lII:If.Do1eDt
to
4eeor1be
the
dev1oe.
Ita
lDten4e4
ue.
and
the
d1reo-
ttODli
for
Ita
ue.
Where
applicable,
pho-
tosraPha
or
enr1DeerI..Dr
draw1nrll
ahould
be
aupp11ed.
(f)
A
ata.tement
tndicattDg
the
device
18
III.m1la.r
to
and/or
dlft'erant
from
othel'
produota
of
compara,ble
t;r;pe
lD
oommero1aJ. dlatrlbutlOD,
acco~
b7
data
to
aupport
the
ltatement.
T.b1a
information
ma.y lDolude
an
ldentlf1c&..
ttOD
or
mmUM
prodnote.
ma.ter1aJ.a,
de-
Idirn ooDB1deratiODll. enet'Ir.Y
apected
to
be
WIe4
or
delivered.
by
the
device.
and
a 4eecr1pt1on
of
the
0perat10D&l
priIl-
o1plea
or
the
device.
<&')
Wh.re
a perIIOn requ:1red
to
reg-
later
lDten411
to
lDtl'oduoe
into
c0m-
mercial
41atr1bution a
device
thlLt
hu
1lJl4errone a
1Iipf110000t
cha.:Dre
or
mod11leatlon
that
could
1I11Pl11lO&lltJ:v
affect
the
aafety
or
eft'eotlV8DIIIIII
of
the
dev1oe.
or
the
cIevlce ill
to
be
marketed
for
a
DeW
or
different
lD41oa.tion
for
uae.
the
prema.r:tet
DoWleation
BUb-
miaII10n
mut
lDolude appro:Pr1ate IUP-
port1nr
data
to
show
tha.t
the
manufao...
tu:rer
bas
ooD.l1dere4
w.bat
con-
aequenoea
a.nd eft'eotll
the
ol:IaIlge
or
modifloation
or
new
ue
mirht
lI&ve
on
the
116fet:v
and
etreot1veu.eaa
or
the
de-
viae.
(h)
A
510(11:)
1IUl1UD&1'J'
..
deacribed
lD
IIIO'FJI'J
or
a
510(11:)
statement
as
de-
ICr1bed lD
18O'l.98.
(1)
Par
aubm1aaiODli
ola1:m1nr
.lIUbatan-
t1al
eq1dvalenoe
to
a
device
which
bas
been
oJlaaffled
into
olalla m
uDder
sec-
tl0ll513(b)
of
the
act: