+--------------------+-------+-----+------------------+---------------+
| **DEPARTMENT OF    |       |     | *Form Approved   |               |
| HEALTH AND HUMAN   |       |     | OMB No.          |               |
| SERVICES\          |       |     | 0910-0025*       |               |
| **PUBLIC HEALTH    |       |     |                  |               |
| SERVICE\           |       |     | *Expiration      |               |
| FOOD AND DRUG      |       |     | Date: December   |               |
| ADMINISTRATION     |       |     | 31, 2006.*       |               |
|                    |       |     |                  |               |
| **DECLARATION FOR  |       |     |                  |               |
| IMPORTED\          |       |     |                  |               |
| ELECTRONIC         |       |     |                  |               |
| PRODUCTS SUBJECT   |       |     |                  |               |
| TO RADIATION       |       |     |                  |               |
| CONTROL            |       |     |                  |               |
| STANDARDS**        |       |     |                  |               |
+--------------------+-------+-----+------------------+---------------+
|                    |       |     | **INSTRUCTIONS** |               |
|                    |       |     |                  |               |
|                    |       |     | 1\. If           |               |
|                    |       |     | submitting       |               |
|                    |       |     | entries          |               |
|                    |       |     | electronically   |               |
|                    |       |     | through ACS/ABI, |               |
|                    |       |     | hold FDA-2877 in |               |
|                    |       |     | entry file. Do   |               |
|                    |       |     | not submit to    |               |
|                    |       |     | FDA unless       |               |
|                    |       |     | requested.       |               |
|                    |       |     |                  |               |
|                    |       |     | 2\. If           |               |
|                    |       |     | submitting paper |               |
|                    |       |     | entry documents, |               |
|                    |       |     | submit the       |               |
|                    |       |     | following to     |               |
|                    |       |     | FDA:             |               |
|                    |       |     |                  |               |
|                    |       |     | a\. 2 copies of  |               |
|                    |       |     | Customs Entry    |               |
|                    |       |     | Form (e.g. CF    |               |
|                    |       |     | 3461, CF 3461    |               |
|                    |       |     | Alt, CF 7501,    |               |
|                    |       |     | etc.)            |               |
|                    |       |     |                  |               |
|                    |       |     | b\. 1 copy of    |               |
|                    |       |     | FDA 2877         |               |
|                    |       |     |                  |               |
|                    |       |     | c\. Commercial   |               |
|                    |       |     | Invoice(s) in    |               |
|                    |       |     | English.         |               |
+--------------------+-------+-----+------------------+---------------+
| U.S. CUSTOMS PORT  |       |     | ENTRY NUMBER     | DATE OF ENTRY |
| OF ENTRY           |       |     |                  |               |
|                    |       |     |                  |               |
|                    |       |     |                  |               |
+--------------------+-------+-----+------------------+---------------+
| NAME & ADDRESS OF  |       |     | NAME & ADDRESS   |               |
| MANUFACTURING      |       |     | OF IMPORTER &    |               |
| SITE; COUNTRY OF   |       |     | ULTIMATE         |               |
| ORIGIN             |       |     | CONSIGNEE *(if   |               |
|                    |       |     | not importer)*   |               |
|                    |       |     |                  |               |
|                    |       |     |                  |               |
+--------------------+-------+-----+------------------+---------------+
| PRODUCT            | QUA   |     | MODEL NUMBER(S)  |               |
| DESCRIPTION        | NTITY |     | & BRAND NAME(S)  |               |
|                    | *(Ite |     |                  |               |
|                    | ms/Co |     |                  |               |
|                    | ntain |     |                  |               |
|                    | ers)* |     |                  |               |
|                    |       |     |                  |               |
|                    |       |     |                  |               |
+--------------------+-------+-----+------------------+---------------+
| **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,    |       |     |                  |               |
| > Inves            |       |     |                  |               |
| tigations/Studies, |       |     |                  |               |
| > or Training      |       |     |                  |               |
| > (attach Form FDA |       |     |                  |               |
| > 766)             |       |     |                  |               |
| >                  |       |     |                  |               |
| > 2. Trade         |       |     |                  |               |
| > S                |       |     |                  |               |
| how/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.         |       |     |                  |               |
+--------------------+-------+-----+------------------+---------------+
| > **WARNING: Any   |       | SIG |                  |               |
| > person who       |       | NAT |                  |               |
| > knowingly makes  |       | URE |                  |               |
| > a false          |       | OF  |                  |               |
| > declaration may  |       | IM  |                  |               |
| > be fined not     |       | POR |                  |               |
| > more than        |       | TER |                  |               |
| > \$10,000 or      |       | OF  |                  |               |
| > imprisoned not   |       | REC |                  |               |
| > more than 5      |       | ORD |                  |               |
| > years or both,   |       |     |                  |               |
| > pursuant to      |       |     |                  |               |
| > Title 18 U.S.C.  |       |     |                  |               |
| > 1001. Any person |       |     |                  |               |
| > importing a      |       |     |                  |               |
| > non­compliant     |       |     |                  |               |
| > electronic       |       |     |                  |               |
| > 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.**         |       |     |                  |               |
+--------------------+-------+-----+------------------+---------------+
|                    |       | N   |                  |               |
|                    |       | AME |                  |               |
|                    |       | AND |                  |               |
|                    |       | TI  |                  |               |
|                    |       | TLE |                  |               |
|                    |       | OF  |                  |               |
|                    |       | RE  |                  |               |
|                    |       | SPO |                  |               |
|                    |       | NSI |                  |               |
|                    |       | BLE |                  |               |
|                    |       | PER |                  |               |
|                    |       | SON |                  |               |
|                    |       |     |                  |               |
|                    |       |     |                  |               |
|                    |       |     |                  |               |
+--------------------+-------+-----+------------------+---------------+
| > **Public         |       |     |                  |               |
| > reporting burden |       |     |                  |               |
| > for this         |       |     |                  |               |
| > collection of    |       |     |                  |               |
| > information** is |       |     |                  |               |
| > estimated to     |       |     |                  |               |
| > average 0.2 hour |       |     |                  |               |
| > per response,    |       |     |                  |               |
| > including the    |       |     |                  |               |
| > time for         |       |     |                  |               |
| > reviewing        |       |     |                  |               |
| > instructions,    |       |     |                  |               |
| > searching        |       |     |                  |               |
| > existing data    |       |     |                  |               |
| > sources,         |       |     |                  |               |
| > gathering and    |       |     |                  |               |
| > maintaining the  |       |     |                  |               |
| > data needed, and |       |     |                  |               |
| > completing       |       |     |                  |               |
| > reviewing 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:       |       |     |                  |               |
| >                  |       |     |                  |               |
| > Food and Drug    |       |     |                  |               |
| > Administration\  |       |     |                  |               |
| > CDRH (HFZ-342)\  |       |     |                  |               |
| > 2094 Gaither     |       |     |                  |               |
| > Road\            |       |     |                  |               |
| > Rockville, MD    |       |     |                  |               |
| > 20850            |       |     |                  |               |
| >                  |       |     |                  |               |
| > *An agency may   |       |     |                  |               |
| > not conduct or   |       |     |                  |               |
| > sponsor, and a   |       |     |                  |               |
| > person is not    |       |     |                  |               |
| > required to      |       |     |                  |               |
| > respond to, a    |       |     |                  |               |
| > collection of    |       |     |                  |               |
| > information      |       |     |                  |               |
| > unless it        |       |     |                  |               |
| > displays a       |       |     |                  |               |
| > currently valid  |       |     |                  |               |
| > OMB control      |       |     |                  |               |
| > number.*         |       |     |                  |               |
+--------------------+-------+-----+------------------+---------------+

> **INSTRUCTIONS TO IMPORTERS/BROKERS OF ELECTRONIC PRODUCTS**
>
> **PURPOSE:** The Form FDA 2877 must be completed for electronic
> products subject to Radiation Control Standards (21 CFR 1010 and
> 1020-1050) prior to entry into the United States. The local Food and
> Drug Administration (FDA) district office will review the declaration
> and notify the importer/agent if the products may be released into
> U.S. commerce or if they must be held under bond until exported,
> destroyed, or reconditioned. Until the shipment is released, it may be
> subject to redelivery for FDA examination.
>
> **PAPER OR ELECTRONIC SUBMISSION:** Paper entries may be made by
> submitting the signed original FDA 2877 along with U.S. Customs forms
> to the local FDA district office; if electronic products are given a
> MAY PROCEED, a signed copy of CF 3461 will be returned, or if not
> given a MAY PROCEED, a FDA Notice of Action will be issued. For
> electronic entries, follow U.S. Customs Service ACS/ABI format and
> procedures, supported by a signed copy of this form or similar letter.
> Multiple entries of the same product and model families that are filed
> electronically may be supported by one form dated not more than 12
> months previously.
>
> **DECLARATION:** Select A, B, C, or D and then select the appropriate
> number; fill in requested information and sign. For electronic
> entries, AofC (affirmation of compliance) = RA#, RB#, RC#, or RD#
> (e.g., Radiation Declaration A5 = RA5). **Transmit model number using
> AofC code MDL and transmit brand name using FDA line level brand name
> field. If RA3 or RA6 is selected, you must transmit quantity (number
> of units) using the Quantity and Unit of Measure Pairs at the FDA line
> level.**
>
> **DECLARATION A:** Importers should be prepared to demonstrate
> compliance to or non-applicability of FDA standards, regulations, or
> guidance. Components or sub-assemblies must be non-functioning.
> Products being reprocessed must be exported by the importer, without
> intermediate transfer of ownership. For RA3 the quantity limit is 3
> and for RA6 the limit = 50 units TV products, microwave ovens, and
> Class 1 laser products limit = 200 units CD-ROM and DVD (digital
> versatile disc) laser products; see May 14, 1997, notice to industry
> issued by the Center for Devices and Radiological Health (CDRH).
>
> **DECLARATION B:** If declaration RB1 is selected, provide the FDA
> Establishment Identifier (FEI) of the manufacturer who filed the
> radiation product/abbreviated report to FDA, CDRH, Rockville,
> Maryland. To transmit the accession number of that report use AofC
> code ACC. If the manufacturer cannot be determined or located, the
> importer must be able to provide evidence showing a certification
> (certifi.) label on each product and state reason: returned to orig
> exporter or certifi. label evidence. The new AofC codes (RB1, RB2) for
> this declaration will not be activated until a process is made
> available to determine the FEI of the responsible firm. Continue to
> use RAB in electronic transmission until the FEI query is available
> and industry is notified of its availability.
>
> **DECLARATION C:** Noncompliant products may be imported only for
> research, investigations/studies, demonstration or training. They
> should be used only by trained personnel and under controlled
> conditions to avoid unnecessary radiation exposure. Product(s) will be
> detained by the local FDA district office. Since product(s) for which
> \"C\" Declarations are made will be under Temporary Import Bond (TIB)
> or equivalent, ultimate disposition is limited to export or
> destruction under U.S. Customs supervision when the purpose has been
> achieved or the length of time stated has expired. For purposes other
> than demonstration, the Form FDA 766, outlining protections, must be
> approved by FDA prior to use. The importer/broker must include with
> the FDA 766:
>
> 1\. A full description of the subject electronic product(s).
>
> 2\. The purpose for which the product(s) is being imported.
>
> 3\. How the product(s) will be used.
>
> 4\. Where the product(s) will be located.
>
> 5\. The approximate length of time and dates the product(s) will be in
> this country.
>
> For product(s) being used for trade shows/demonstrations, list the
> dates and use restrictions (Form FDA 766 is not required). A sign
> stating that the product does not comply with FDA performance
> standards must be displayed and viewable at all times during the use
> of product(s). All medical products, cabinet x-ray, or Class IIIb and
> IV lasers may NOT operate (turn on product(s)) at trade shows.
>
> **DECLARATION D:** Noncompliant products must be brought into
> compliance with standards under FDA supervision and following a plan
> approved by FDA. The plan, documented on the Form FDA 766, must
> address technical requirements, labeling, and reporting. Some plans
> may need approval by both the CDRH and the local FDA district office.
> Use of this declaration is limited to occasional shipments; ongoing
> reconditioning is considered manufacturing that is handled through
> other means. Product(s) will be detained by the local FDA district
> office. An FDA 766 must be filed indicating the procedure intended to
> bring the product into compliance. This procedure will include a
> satisfactory corrective action plan and/or a product report. The FDA
> 766 must include all of the information requested under Declaration C.
> The approximate length of time will be for the amount of time needed
> to bring product(s) into compliance. Declaration D is also made for
> failure to provide reports, failure to certify, etc.
>
> If an importer/broker intends to import equipment into the United
> States for purposes of research, investigation, studies,
> demonstrations, or training but also wishes to retain the option of
> bringing the product into compliance with the performance standard,
> check Declarations C and D on the FDA 2877 and insert the word \"or \"
> between the Affirmations. Note: The U.S. Customs Service will treat
> this entry as a \"D\" Declaration for purposes of duty. Such requests
> must be made on the FDA 766; include Items 1, 2, and 3 under
> Declaration C, a statement of the need to use the option \"C\" or
> \"D\" Declaration, a statement of how the product(s) will be brought
> into compliance and the approximate length of time necessary to
> evaluate or demonstrate the product(s) and the time necessary to bring
> the product(s) into compliance (both actions must be accomplished
> within the period of time granted by FDA). For electronic entries
> select Declaration RD3.
>
> Ultimately, product(s) must be brought into compliance with the
> applicable standard in accordance with a corrective action plan which
> has been approved by the FDA. If the product(s) are not brought into
> compliance within the allotted time frame of the approved application
> and an extension is not requested of, or granted by, the FDA, the
> local FDA district office shall refuse entry on the shipment and
> require the product(s) to be either exported or destroyed under U.S.
> Customs supervision.
>
> If additional guidance is needed, please contact your local FDA
> district office or consult the following FDA web pages:
> www.fda.gov/cdrh, www.fda.gov/ora/hier/ora_field_names.txt, and
> www.fda.gov/ora/compliance_ref/rpm_new2/contens.html.
>
> \[Ref: 21 U.S.C. 360mm, 21 CFR 1005, 19 CFR 12.90-12.91.\] FDA: CP
> 7382.007/.007A