Subpart D-Exemptions From
Notification Requirements

§1003.30 Application for exemption from notification requirements.

(a) A manufacturer may at the time of giving the written confirmation required by §1003.20 or within 15 days of the receipt of any notice from the Secretary pursuant to § 1003.11(a), apply for an exemption from the requirement of notice to the persons specified in § 1003.10(b).

(b) The application for exemption shall contain the information required by $1003.20 and in addition shall set forth in detail the grounds upon which the exemption is sought.

§ 1003.31 Granting the exemption.

(a) If, in the judgment of the Secretary, the application filed pursuant to §1003.30 states reasonable grounds for an exemption from the requirement of notice, the Secretary shall give the manufacturer written notice specifying a reasonable period of time during which he may present his views and evidence in support of the application.

(b) Such views and evidence shall be confined to matters relevant to whether the defect in the product or its failure to comply with an applicable Federal standard is such as to create a significant risk of injury, including genetic injury, to any person and shall be presented in writing unless the Secretary determines that an oral presentation is desirable. Where such evidence includes nonclinical laboratory studies, the data submitted shall include, with respect to each such study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. When such evidence includes clinical investigations involving human subjects, the data submitted shall include, with respect to each clinical investigation either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with §56.104 or

§ 56.105, and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(c) If, during the period of time afforded the manufacturer to present his views and evidence, the manufacturer proves to the Secretary's satisfaction that the defect or failure to comply does not create a significant risk of injury, including genetic injury, to any person, the Secretary shall issue an exemption from the requirement of notification to the manufacturer and shall notify the manufacturer in writing specifying:

(1) The electronic product or products for which the exemption has been issued; and

(2) Such conditions as the Secretary deems necessary to protect the public health and safety.

(d) Any person who contests denial of an exemption shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.

[38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 FR 15676, Mar. 22, 1977; 50 FR 7518, Feb. 22, 1985]

PART 1004-REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS

Sec.

1004.1 Manufacturer's obligation to repair, replace, or refund cost of electronic products.

1004.2 Plans for the repair of electronic products.

1004.3 Plans for the replacement of electronic products.

1004.4 Plans for refunding the cost of electronic products.

1004.6 Approval of plans.

AUTHORITY: 42 U.S.C. 263b-263n.

SOURCE: 38 FR 28629, Oct. 15, 1973, unless otherwise noted.

§ 1004.1 Manufacturer's obligation to repair, replace, or refund cost of electronic products.

(a) If any electronic product fails to comply with an applicable Federal standard or has a defect and the notification specified in §1003.10(b) of this chapter is required to be furnished, the manufacturer of such product shall;

(1) Without charge, bring such product into conformity with such standard or remedy such defect and provide reimbursement for any expenses for transportation of such product incurred in connection with having such product brought into conformity or having such defect remedied; or

(2) Replace such product with a like or equivalent product which complies with each applicable Federal standard and which has no defect relating to the safety of its use; or

(3) Make a refund of the cost of the product to the purchaser.

(b) The manufacturer shall take the action required by this section in accordance with a plan approved by the Secretary pursuant to § 1004.6.

§ 1004.2 Plans for the repair of electronic products.

Every plan for bringing an electronic product into conformity with applicable Federal standards or for remedying any defect in such product shall be submitted to the Secretary in writing, and in addition to other relevant information which the Secretary may require, shall include:

(a) Identification of the product involved.

(b) The approximate number of defective product units which have left the place of manufacture.

(c) The specific modifications, alterations, changes, repairs, corrections, or adjustments to be made to bring the product into conformity or remedy any defect.

(d) The manner in which the operations described in paragraph (c) will be accomplished, including the procedure for obtaining access to, or possession of, the products and the location where such operations will be performed.

(e) The technical data, test results or studies demonstrating the effectiveness of the proposed remedial action.

(f) A time limit, reasonable in light of the circumstances, for completion of the operations.

(g) The system by which the manufacturer will provide reimbursement for any transportation expenses incurred in connection with having such product brought into conformity or having any defect remedied.

(h) The text of the statement which the manufacturer will send to the persons specified in §1003.10(b) of this chapter informing such persons;

(1) That the manufacturer, at his expense, will repair the electronic product involved,

(2) of the method by which the manufacturer will obtain access to or possession of the product to make such repairs,

(3) That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with making such repairs, and

(4) of the manner in which such reimbursement will be effected.

(i) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of electronic products repaired.

§ 1004.3 Plans for the replacement of electronic products.

Every plan for replacing an electronic product with a like or equivalent product shall be submitted to the Secretary in writing, and in addition to other relevant information which the Secretary may require, shall include:

(a) Identification of the product to be replaced.

(b) A description of the replacement product in sufficient detail to support the manufacturer's contention that the replacement product is like or equivalent to the product being replaced.

(c) The approximate number of defective product units which have left the place of manufacture.

(d) The manner in which the replacement operation will be effected including the procedure for obtaining possession of the product to be replaced.

(e) A time limit, reasonable, in light of the circumstances for completion of the replacement.

(f) The steps which the manufacturer will take to insure that the defective product will not be reintroduced into commerce, until it complies with each applicable Federal standard and has no defect relating to the safety of its use.

(g) The system by which the manufacturer will provide reimbursement for any expenses for transportation of such product incurred in connection with effecting the replacement.

(h) The text of the statement which the manufacturer will send to the persons specified in §1003.10(b) of this chapter informing such persons;

(1) That the manufacturer, at its expense, will replace the electronic product involved,

(2) of the method by which the manufacturer will obtain possession of the product and effect the replacement,

(3) That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with effecting such replacement, and

(4) of the manner in which such reimbursement will be made.

(i) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of electronic products replaced.

§ 1004.4 Plans for refunding the cost of electronic products.

Every plan for refunding the cost of an electronic product shall be submitted to the Secretary in writing, and in addition to other relevant information which the Secretary may require, shall include:

(a) Identification of the product involved.

(b) The approximate number of defective product units which have left the place of manufacture.

(c) The manner in which the refund operation will be effected including the procedure for obtaining possession of the product for which the refund is to be made.

(d) The steps which the manufacturer will take to insure that the defective products will not be reintroduced into commerce, until it complies with each applicable Federal standard and has no defect relating to the safety of its use. (e) A time limit, reasonable in light of the circumstances, for obtaining the product and making the refund.

(f) A statement that the manufacturer will refund the cost of such product together with the information the manufacturer has used to determine the amount of the refund.

(g) The text of the statement which the manufacturer will send to the persons specified in §1003.10(b) of this chapter informing such persons;

(1) That the manufacturer, at his expense, will refund the cost of the electronic product plus any transportation costs,

(2) Of the amount to be refunded exclusive of transportation costs,

(3) of the method by which the manufacturer will obtain possession of the product and make the refund.

(h) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of refunds made.

§ 1004.6 Approval of plans.

If, after review of any plan submitted pursuant to this subchapter, the Secretary determines that the action to be taken by the manufacturer will expeditiously and effectively fulfill the manufacturer's obligation under §1004.1 in a manner designed to encourage the public to respond to the proposal, the Secretary will send written notice of his approval of such plan to the manufacturer. Such approval may be conditioned upon such additional terms as the Secretary deems necessary to protect the public health and safety. Any person who contests denial of a plan shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.

[38 FR 28629, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 FR 15676, Mar. 22, 1977]

1005.22 Granting permission to bring prod

uct into compliance.

1005.23 Bonds.

1005.24 Costs of bringing product into compliance.

1005.25 Service of process on manufacturers.

AUTHORITY: 42 U.S.C. 263d, 263h.

SOURCE: 38 FR 28630, Oct. 15, 1973, unless otherwise noted.

Subpart A-General Provisions

$1005.1 Applicability.

(a) The provisions of §§ 1005.1 through 1005.24 are applicable to electronic products which are subject to the standards prescribed under this subchapter and are offered for importation into the United States.

(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.

[38 FR 28630, Oct. 15, 1973, as amended at 45 FR 81739, Dec. 12, 1980]

§ 1005.2 Definitions.

As used in this part:

The term owner or consignee means the person who has the rights of a consignee under the provisions of sections 483, 484, and 485 of the Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).

§ 1005.3 Importation of noncomplying goods prohibited.

The importation of any electronic product for which standards have been prescribed under section 358 of the Act (42 U.S.C. 263f) shall be refused admission into the United States unless there is affixed to such product a certification in the form of a label or tag in conformity with section 358(h) of the Act (42 U.S.C. 263f(h)). Merchandise refused admission shall be destroyed or exported under regulations prescribed by the Secretary of the Treasury unless a timely and adequate petition for permission to bring the product into compliance is filed and granted under §§ 1005.21 and 1005.22.

Subpart B-Inspection and Testing

§ 1005.10 Notice of sampling.

When a sample of a product to be offered for importation has been requested by the Secretary, the District Director of Customs having jurisdiction over the shipment shall, upon the arrival of the shipment, procure the sample and shall give to its owner or consignee prompt notice of the delivery or of the intention to deliver such sample to the Secretary. If the notice so requires, the owner or consignee will hold the shipment of which the sample is typical and not release such shipment until he receives notice of the results of the tests of the sample from the Secretary, stating that the product is in compliance with the requirements of the Act. The District Director of Customs will be given the results of the tests. If the Secretary notifies the District Director of Customs that the product does not meet the requirements of the Act, the District Director of Customs shall require the exportation or destruction of the shipment in accordance with customs laws.

§ 1005.11 Payment for samples.

The Department of Health and Human Services will pay for all import samples of electronic products rendered unsalable as a result of testing, or will pay the reasonable costs of repackaging such samples for sale, if the samples are found to be in compliance with the requirements of the Radiation Control for Health and Safety Act of 1968. Billing for reimbursement shall be made by the owner or consignee to the Center for Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857. Payment for samples will not be made if the sample is found to be in violation of the Act, even though subsequently brought into compliance pursuant to terms specified in a notice of permission issued under § 1005.22.

[38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988]

Subpart C-Bonding and
Compliance Procedures

§ 1005.20 Hearing.

(a) If, from an examination of the sample or otherwise, it appears that the product may be subject to a refusal of admission, the Secretary shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony unless the owner or consignee indicates his intention to bring the product into compliance. Upon timely request, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility of the article and may be introduced orally or in writing.

(b) If the owner or consignee submits or indicates his intention to submit an application for permission to perform such action as is necessary to bring the product into compliance with the Act, such application shall include the information required by § 1005.21.

(c) If the application is not submitted at or prior to the hearing, the Secretary may allow a reasonable time for filing such application.

§ 1005.21 Application for permission to bring product into compliance. Application for permission to perform such action as is necessary to bring the product into compliance with the Act may be filed only by the owner, consignee, or manufacturer and, in addition to any other information which the Secretary may reasonably require, shall:

(a) Contain a detailed proposal for bringing the product into compliance with the Act;

(b) Specify the time and place where such operations will be effected and the approximate time for their completion;

and

(c) Identify the bond required to be filed pursuant to § 1005.23.

§ 1005.22 Granting permission to bring product into compliance.

(a) When permission contemplated by §1005.21 is granted, the Secretary shall

notify the applicant in writing, specifying:

(1) The procedure to be followed;

(2) The disposition of the rejected articles or portions thereof;

(3) That the operations are to be carried out under the supervision of a representative of the Department of Health and Human Services;

(4) A reasonable time limit for completing the operations; and

(5) Such other conditions as he finds necessary to maintain adequate supervision and control over the product.

(b) Upon receipt of a written request for an extension of time to complete the operations necessary to bring the product into compliance, the Secretary may grant such additional time as he deems necessary.

(c) The notice of permission may be amended upon a showing of reasonable grounds thereof and the filing of an amended application for permission with the Secretary.

(d) If ownership of a product included in a notice of permission changes before the operations specified in the notice have been completed, the original owner will remain responsible under its bond, unless the new owner has executed a superseding bond on customs Form 7601 and obtained a new notice.

(e) The Secretary will notify the District Director of Customs having jurisdiction over the shipment involved, of the determination as to whether or not the product has in fact been brought into compliance with the Act.

§ 1005.23 Bonds.

The bond required under section 360(b) of the Act shall be executed by the owner or consignee on the appropriate form of a customs single-entry bond, customs Form 7551 or term bond, customs Form 7553 or 7595, containing a condition for the redelivery of the shipment or any part thereof not complying with the laws and regulations governing its admission into the commerce of the United States upon demand of the District Director of Customs and containing a provision for the performance of any action necessary to bring the product into compliance with all applicable laws and regulations. The bond shall be filed with the District Director of Customs.