Form Fda 2877 - Declaration For Imported Electronic Products Subject To Radiation Control Standards - Department Of Health And Human Services

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Form Approved OMB No. 0910-0025

Expiration Date: January 31, 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICES

INSTRUCTIONS

FOOD AND DRUG ADMINISTRATION

1. If submitting entries electronically through ACS/ABI, hold FDA-2877 in

DECLARATION FOR IMPORTED

entry file. Do not submit to FDA unless requested.

2. If submitting paper entry documents, submit the following to FDA:

ELECTRONIC PRODUCTS SUBJECT TO

a. 2 copies of Customs Entry Form (e.g. CF 3461, CF 3461 Alt,

RADIATION CONTROL STANDARDS

CF 7501, etc.)

b. 1 copy of FDA 2877

c. Commercial Invoice(s) in English.

U.S. CUSTOMS PORT OF ENTRY

ENTRY NUMBER

DATE OF ENTRY

NAME & ADDRESS OF MANUFACTURING SITE; COUNTRY OF ORIGIN

NAME & ADDRESS OF IMPORTER & ULTIMATE CONSIGNEE (if not importer)

PRODUCT DESCRIPTION

QUANTITY (Items/Containers)

MODEL NUMBER(S) & BRAND NAME(S)

DECLARATION: I / WE DECLARE THAT THE PRODUCTS IDENTIFIED ABOVE:

(Mark X applicable statements, fill in blanks, & sign)

A. ARE NOT SUBJECT TO RADIATION PERFORMANCE STANDARDS BECAUSE THEY:

1. Were manufactured prior to the effective date of any applicable standard; Date of Manufacture

2. Are excluded by the applicability clause or definition in the standard or by FDA written guidance.

Specify reason for exclusion

3. Are personal household goods of an individual entering the U.S. or being returned to a U.S. resident. (Limit: 3 of each product type).

4. Are property of a party residing outside the U.S. and will be returned to the owner after repair or servicing.

5. Are components or subassemblies to be used in manufacturing or as replacement parts (NOT APPLICABLE to diagnostic x-ray parts).

6. Are prototypes intended for on going product development by the importing firm, are labeled "FOR TEST/EVALUATION ONLY," and will be exported,

destroyed, or held for future testing (i.e., not distributed). (Quantities Limited - see reverse.)

7. Are being reprocessed in accordance with P.L. 104-134 or other FDA guidance, are labeled "FOR EXPORT ONLY," and will not be sold, distributed,

or transferred without FDA approval.

B. COMPLY WITH THE PERFORMANCE STANDARDS WHICH ARE APPLICABLE AT DATE OF MANUFACTURE AND THAT A

CERTIFICATION LABEL OR TAG TO THIS EFFECT IS AFFIXED TO EACH PRODUCT. COMPLIANCE DOCUMENTED IN:

1. Last annual report or Product/Initial report

ACCESSION NUMBER of Report

Name of MANUFACTURER OF RECORD (Filed report with FDA/CDRH)

2. Unknown manufacturer or report number; State reason:

C. DO NOT COMPLY WITH PERFORMANCE STANDARDS; ARE BEING HELD UNDER A TEMPORARY IMPORT BOND; WILL NOT

BE INTRODUCED INTO COMMERCE; WILL BE USED UNDER A RADIATION PROTECTION PLAN; AND WILL BE DESTROYED

OR EXPORTED UNDER U.S. CUSTOMS SUPERVISION WHEN THE FOLLOWING MISSION IS COMPLETE:

1. Research, Investigations/Studies, or Training (attach Form FDA 766)

2. Trade Show/Demonstration; List dates & use restrictions

D. DO NOT COMPLY WITH PERFORMANCE STANDARDS; ARE HELD AND WILL REMAIN UNDER BOND; AND WILL NOT BE

INTRODUCED INTO COMMERCE UNTIL NOTIFICATION IS RECEIVED FROM FDA THAT PRODUCTS HAVE BEEN BROUGHT

INTO COMPLIANCE IN ACCORDANCE WITH AN FDA APPROVED PETITION. (See Form FDA 766.)

1. Approved Petition is attached.

2. Petition Request is attached.

3. Request will be submitted within 60 days.

SIGNATURE OF IMPORTER OF RECORD

WARNING: Any person who knowingly makes a false

declaration may be fined not more than $10,000 or imprisoned

not more than 5 years or both, pursuant to Title 18 U.S.C.

1001. Any person importing a non-compliant electronic

NAME AND TITLE OF RESPONSIBLE PERSON

product may also be subject to civil penalties of $1000 per

violation, up to a maximum $300,000 for related violations

pursuant to Title 21 U.S.C. 360pp.

Public reporting burden for this collection of information is estimated to average 0.2 hour per response, including the time to review instructions, search existing

data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other

aspect of this collection of information, including suggestions for reducing this burden, to:

Department of Health and Human Services

Do not send your completed form to the PRA Staff email address to the left.

Food and Drug Administration

Office of Chief Information Officer

An agency may not conduct or sponsor, and a person is not required to respond to, a

Paperwork Reduction Act (PRA) Staff

collection of information unless it displays a currently valid OMB control number.

PRAStaff@fda.hhs.gov

FORM FDA 2877 (8/14)

PREVIOUS EDITION IS OBSOLETE.

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