RADIATION CONTROL STANDARDS

Form Approved OMB No. 57-R0120

INSTRUCTIONS

1. Type or print with ball point pen.

2. Submit one copy with U.S. Customs Service Entry Papers.

3. Attach two copies to Form FD 701, “Importer Entry Notice.”

DISTRICT/PORT DIRECTOR OF CUSTOMS

PORT OF ENTRY

ENTRY NO.

DATE

PRODUCT IDENTIFICATION

NAME AND ADDRESS OF MANUFACTURER

NAME AND ADDRESS OF IMPORTER OF RECORD

ULTIMATE CONSIGNEE (If not Importer of Record)

QUANTITY

TYPE

BRAND NAME

MODEL NO.

FOR X-RAY, LIST APPROPRIATE SYSTEM OR COMPONENT CATEGORY

AFFIRMATION (Check appropriate statement and sign)

I/We hereby declare

------ A. That the electronic products identified above were manufactured prior to the date of any applicable electronic product

performance standard.

Date of Manufacture

----- B. That the electronic products identified above comply with the performance standards prescribed in Food and Drug

Administration Rules 21 CFR 1010 which are applicable at date of manufacture and that a certificate in the form of a tag or label to

effect is affixed to each product.

------ C. That the electronic products identified above do not comply with the performance standards prescribed in Food and Drug

Administration Rules 21 CFR but are being imported for the purpose of research, investigations, studies, demonstrations,

or training. An exemption for these product has been or will be requested of the Director of the FDA Bureau of Radiological

Health in accord with Section 360B (b) (42 U.S.C. 263j) of the Radiation Control for Health and Safety Act. They will not

be introduced into commerce, and when their mission is completed they will be destroyed or exported under United

States Customs Service supervision

------ D. That the electronic products identified above do not comply with the performance standards prescribed in Food and

Drug Administration Rules 21 CFR 1010 but that a timely and adequate petition for permission to bring the product into

compliance with the applicable standard has been or will be field with the Food and Drug Administration in accordance

with 21 CFR 1005.21. These products will remain under bond and not be introduced into commerce until notification is

received from the Food and Drug Administration, that the the products are in compliance with applicable standards.

Signature of Importer of Record

1 Facsimile of signature not acceptable

FORM FD 2877 (9/77) AWB# RETURN TO