Form 2877 - Declaration For Imported Electronic Products Subject To Radiation Control Standards

Download a blank fillable Form 2877 - Declaration For Imported Electronic Products Subject To Radiation Control Standards in PDF format just by clicking the "DOWNLOAD PDF" button.

Open the file in any PDF-viewing software. Adobe Reader or any alternative for Windows or MacOS are required to access and complete fillable content.

Complete Form 2877 - Declaration For Imported Electronic Products Subject To Radiation Control Standards with your personal data - all interactive fields are highlighted in places where you should type, access drop-down lists or select multiple-choice options.

Some fillable PDF-files have the option of saving the completed form that contains your own data for later use or sending it out straight away.

F orm A pproved OMB No. 0910-0025

DE P A R T ME NT OF HE A L T H A ND HUMA N S E R V IC E S

E xpiration Date: 11/30/2003

P UB L IC HE A L T H S E R V IC E

INS T R UC T IONS

F OOD A ND DR UG A DMINIS T R A T ION

1. If s ubmittingentries elec tronic allythroughA C S /A B I, hold F DA -2877 in

entry file. Do not s ubmitto F DA unles s reques ted.

DE C L A R A T ION F OR IMP OR T E D

2. If s ubmittingpaper entry doc uments ,s ubmitthe followingto F DA :

a. 2 c opies of C us toms E ntry F orm (e.g. C F 3461, C F 3461 A lt,

E L E C T R ONIC P R ODUC T S S UB J E C T T O

C F 7501, etc .)

R A DIA T ION C ONT R OL S T A NDA R DS

b. 1 c opy of F DA 2877

c . C ommerc ialInvoic e(s )in E nglis h.

U.S . C US T OMS P OR T OF E NT R Y

E NT R Y NUMB E R

DA T E OF E NT R Y

NA ME & A DDR E S S OF MA NUF A C T UR ING S IT E ; C OUNT R Y OF OR IG IN

NA ME & A DDR E S S OF IMP OR T E R & UL T IMA T E C ONS IG NE E (if notimporter)

P R ODUC T DE S C R IP T ION

QUA NT IT Y (Items /C ontainers )

MODE L NUMB E R (S ) & B R A ND NA ME (S )

(Mark

applic able s tatements , fill in blanks , & s ign)

DE C L A R A T ION: I / WE DE C L A R E T HA T T HE P R ODUC T S IDE NT IF IE D A B OV E :

A .

A R E NOT S UB J E C T T O R A DIA T ION P E R F OR MA NC E S T A NDA R DS B E C A US E T HE Y :

1. Were manufac turedpriorto the effec tive date of any applic ables tandard; Date of Manufac ture _______________________________ .

2. A re exc luded by the applic ability c laus e or definitionin the s tandardor by F DA written guidanc e.

S pec ify reas on for exc lus ion ______________________________________________________________.

3. A re pers onalhous eholdgoods of an individualentering the U.S . or beingreturned to a U.S . res ident. (L imit: 3 of eac h produc ttype).

4. A re propertyof a party res idingouts idethe U.S . and willbe returned to the owner after repair or s ervic ing.

5. A re c omponentsor s ubas s embliesto be us ed in manufac turingor as replac ementparts (NOT A P P L IC A B L E to diagnos ticx-ray parts ).

6. A re prototypesintendedfor on going produc tdevelopmentby the importingfirm, are labeled " F OR T E S T /E V A L UA T ION ONL Y ," and will be exported,

des troyed,or held for future tes ting (i.e., not dis tributed). (Quantities L imited- s ee revers e.)

7. A re being reproc es s edin ac c ordanc ewithP .L . 104-134 or other F DA guidanc e,are labeled" F OR E XP OR T ONL Y ," and will not be s old, dis tributed,

or trans ferredwithoutF DA approval.

B . C OMP L Y WIT H T HE P E R F OR MA NC E S T A NDA R DS WHIC H A R E A P P L IC A B L E A T DA T E OF MA NUF A C T UR E A ND T HA T A

C E R T IF IC A T ION L A B E L OR T A G T O T HIS E F F E C T IS A F F IXE D T O E A C H P R ODUC T . C OMP L IA NC E DOC UME NT E D IN:

1. L as tannual reportor P roduc t/Initial r eport

______________________________

_________________________________________________________

_________

A C C E S S ION NUMB E R of R eport

Name of MA NUF A C T UR E R OF R E C OR D (F iled report withF DA /C DR H)

2. Unknownmanufac tureror reportnumber; S tate reas on:

___________________________________________________________________

C . DO NOT C OMP L Y WIT H P E R F OR MA NC E S T A NDA R DS ; A R E B E ING HE L D UNDE R A T E MP OR A R Y IMP OR T B OND; WIL L NOT

B E INT R ODUC E D INT O C OMME R C E ; WIL L B E US E D UNDE R A R A DIA T ION P R OT E C T ION P L A N; A ND WIL L B E DE S T R OY E D

OR E XP OR T E D UNDE R U.S . C US T OMS S UP E R V IS ION WHE N T HE F OL L OWING MIS S ION IS C OMP L E T E :

1. R es earc h, Inves tigations /S tudies , o r T raining(attac h F orm F DA 766)

2. T rade S how/Demons tration; L is tdates & us e res tric tions ___________________________________________________________

D. DO NOT C OMP L Y WIT H P E R F OR MA NC E S T A NDA R DS ; A R E HE L D A ND WIL L R E MA IN UNDE R B OND; A ND WIL L NOT B E

INT R ODUC E D INT O C OMME R C E UNT IL NOT IF IC A T ION IS R E C E IV E D F R OM F DA T HA T P R ODUC T S HA V E B E E N B R OUG HT

INT O C OMP L IA NC E IN A C C OR DA NC E WIT H A N F DA A P P R OV E D P E T IT ION. (S ee F orm F DA 766.)

1. A pprovedP etitionis attac hed.

2. P etition R eques tis attac hed.

3. R eques twill be s ubmittedwithin60 days .

S IG NA T UR E OF IMP OR T E R OF R E C OR D

WA R NING :

A ny pers on who knowingly makes a fals e

dec laration

may be fined

not more

than $10,000

impris oned not more than 5 years or both, purs uant to T itle

18 U.S .C . 1001.

A ny pers on importing a non- c ompliant

NA ME A ND T IT L E OF R E S P ONS IB L E P E R S ON

elec tronic produc t may als o be s ubjec t to c ivil penalties of

$1000 per violation, up to a maximum $300,000 for related

violations purs uant to T itle 21 U.S .C . 360pp.

P ublic reporting burden for this c ollec tion of information is es timatedto average 0.2 hour per res pons e,inc ludingthe time for reviewing ins truc tions ,

s earc hing exis ting data s ourc es , gathering and maintaining the data needed, and c ompleting reviewing the c ollec tion of information. S end

this burden es timate or any other as pec t of this c ollec tion of information, inc luding s ugges tions for reduc ing this burden to:

F ood and Drug A dminis tration

C DR H (HF Z-342)

2094 G aither R oad

R oc kville, MD 20850

A n agenc y may not c onduc t or s pons or, and a pers on is not required to res pond to, a c ollec tion of information unles s it dis play

F OR M F DA 2877

(12/00)

P R E V IOUS E DIT ION IS OB S OL E T E .

E F

C reated by: P S C Media A rts (301) 443-2454