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Document Effective Date: July 29, 2004
This document supersedes Compliance Policy Guide (CPG) "Sec. 394.500 Importation of Television Receivers and Microwave Ovens for Investigation and Evaluation (CPG 7133.22)" that was issued on March 1, 1984.
At any time, interested persons may submit written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The comments are to be identified with the title of this guidance document. Such comments will be considered when determining whether to amend the current guidance. For questions regarding the use or interpretation of this guidance, contact Jeffrey Governale at 240-632-6851.
Submit written requests for a single copy of this guidance to the Division of Compliance Policy (HFC-230), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-001, or FAX your request to 240-632-6861. A copy of the guidance may also be downloaded to a personal computer with access to the Internet. The Office of Regulatory Affairs’ home page includes the guidance and may be accessed at http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg394-500.html
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidance means that something is suggested or recommended, but not required.
Sec. 394.500 Importation of Television *Products,* Microwave Ovens, *and Inherent Class I Laser Products* for Investigation and Evaluation *during Design Development* (CPG 7133.22)
BACKGROUND:
Federal regulations require that all imported electronic products for which applicable *Food and Drug Administration* (FDA) radiation performance standards exist, shall comply with these standards and shall bear certification of such compliance. Before these products can be permitted to enter the *United States* (U.S.), manufacturers and importers are required to submit with each shipment certain required import entry *information* through the District Director, U.S. Customs *and Border Protection* *(Customs)* to the appropriate FDA district office. *This guidance specifically discusses* imported television *products,* microwave ovens, *and laser products, which* must meet the requirements of performance standards (21 CFR 1020.10, 21 CFR 1030.10, *21 CFR 1040.10, and 21 CFR 1040.11* respectively), or be detained.
*Section 536(a) of the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (the Act) (formerly* the Radiation Control for Health and Safety Act of 1968) *requires that Customs deny entry to any electronic product subject to a radiation performance standard which does not meet such standard or which does not bear certification of compliance with the standard. However, section 536(b) of the Act permits FDA to determine if a product can be brought into compliance with applicable standards upon the filing of an application for admission and posting of a Customs bond, and section 538(b) provides for a possible exemption from certification and certain other requirements pertaining to electronic products when such products are being used for the purposes of research, investigations, studies, demonstrations, or training. Customs regulations (19 CFR 12.90 and 19 CFR 12.91) specify that the importer must file the form FDA 2877 (Declaration for Imported Electronic Products Subject to Radiation Control Standards) declaring whether the electronic products are in compliance and certified as meeting the applicable performance standard.
Current FDA policy is that electronic products, which do not comply with applicable standards, may be imported into the U.S., usually for a period of 180 days, when such products are imported for purposes of research, investigations, studies, demonstrations, or training. During this time, the products remain in import detention status and are allowed into the U.S. if the importer files form FDA 2877, checking Declaration C1 or C2, and form FDA 766 (authorization to relabel or perform other action) with the FDA and files a Temporary Import Bond (TIB) with Customs. Liquidation of the TIB* for these products is attained only through their exportation or destruction.
*Based on its authority under section 538(b) of the Act, FDA in the past has exempted from the requirement to certify to the applicable radiation performance standards shipments of up to 10 units of television products, microwave ovens, and laser products that did not exceed the limits of Class I during any conditions of operation, maintenance, or service (hereafter referred to as inherent Class I laser products) when these products were imported for investigations. These shipments were usually used for acceptance testing (e.g. Federal Communication Commission (FCC) and the Underwriters Laboratories Inc. (UL)), establishment of production line procedures, and applications evaluation. While the products were sometimes fully operational, they were not necessarily the final design and therefore may not have received final acceptance testing and certification. Because there was no commercial distribution of the products, FDA determined that granting the exemption would likely reduce the tracking and paperwork burden on industry, FDA, and Customs, without any adverse impact on the public health.*
POLICY:
*By letter, dated May 14, 1997, FDA determined that the 10 unit exemption was unnecessarily restrictive for certain consumer electronic products (television products, microwave ovens, and inherent Class I laser products) when imported into the U.S. for investigation and evaluation during the design and production development phase. The letter also set forth FDA's decision to increase the number of units of these products that could be imported under the exemption for purposes of investigation and evaluation provided the following conditions are met:
Movement of uncertified products in U.S. commerce is a violation of Section 538(a)(1) of the Act. Violations will result in voiding this exemption for the responsible parties and are subject to civil penalties not to exceed $1,000 per violation and $300,000 maximum for any related series of violations. In addition, providing false information to the U.S. government is a violation of 18 U.S.C. § 1001 and is subject to criminal prosecution.*
*Material between asterisks is new or revised*
Issued: 3/1/84
Revised: 7/29/04
1In 1997, FDA modified form FDA 2877 to include Declaration A6 (Declaration RA6 for electronic filers) which applies specifically to television products, microwave ovens, and inherent Class I laser products.