Title 21—Food and Drugs--Volume 1
PART 1003—NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
§ 1003.1   Applicability.
The provisions of this part are applicable to electronic products which were manufactured after October 18, 1968.
§ 1003.2   Defect in an electronic product.
For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if:
(a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly;
(1) It emits electronic product radiation which creates a risk of injury, including genetic injury, to any person, or
(2) It fails to conform to its design specifications relating to electronic radiation emissions; or
(b) It is a product which utilizes electronic product radiation to accomplish its primary purpose and from which such emissions are intended, and as a result of its design, production or assembly it;
(1) Fails to conform to its design specifications relating to the emission of electronic product radiation; or
(2) Without regard to the design specifications of the product, emits electronic product radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury, including genetic injury to any person; or
(3) Fails to accomplish the intended purpose.
§ 1003.5   Effect of regulations on other laws.
The remedies provided for in this subchapter shall be in addition to and not in substitution for any other remedies provided by law and shall not relieve any person from liability at common law or under statutory law.
§ 1003.10   Discovery of defect or failure of compliance by manufacturer; notice requirements.
Any manufacturer who discovers that any electronic product produced, assembled, or imported by him, which product has left its place of manufacture, has a defect or fails to comply with an applicable Federal standard shall:
(a) Immediately notify the Secretary in accordance with § 1003.20, and
(b) Except as authorized by § 1003.30, furnish notification with reasonable promptness to the following persons:
(1) The dealers or distributors to whom such product was delivered by the manufacturer; and
(2) The purchaser of such product and any subsequent transferee of such product (where known to the manufacturer or where the manufacturer upon reasonable inquiry to dealers, distributors, or purchasers can identify the present user).
(c) If a manufacturer is required to notify the Secretary under paragraph (a) of this section and also is required to report to the Food and Drug Administration under part 803 of this chapter, the manufacturer shall report in accordance with part 803. If a manufacturer is required to notify the Secretary under paragraph (a) of this section and is not required to report to the Food and Drug Administration under part 803, the manufacturer shall notify the Secretary in accordance with paragraph (a) of this section.
§ 1003.11   Determination by Secretary that product fails to comply or has a defect.
(a) If, the Secretary, through testing, inspection, research, or examination of reports or other data, determines that any electronic product does not comply with an applicable Federal standard issued pursuant to the Act or has a defect, he shall immediately notify the manufacturer of the product in writing specifying:
(1) The defect in the product or the manner in which the product fails to comply with the applicable Federal standard;
(2) The Secretary's findings, with references to the tests, inspections, studies, or reports upon which such findings are based;
(3) A reasonable period of time during which the manufacturer may present his views and evidence to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the product by reason of the emission of electronic product radiation.
(b) Every manufacturer who receives a notice under paragraph (a) of this section shall immediately advise the Secretary in writing of the total number of such product units produced and the approximate number of such product units which have left the place of manufacture.
(c) If, after the expiration of the period of time specified in the notice, the Secretary determines that the product has a defect or does not comply with an applicable Federal standard and the manufacturer has not applied for an exemption, he shall direct the manufacturer to furnish the notification to the persons specified in § 1003.10(b) in the manner specified in § 1003.21. The manufacturer shall within 14 days from the date of receipt of such directive furnish the required notification.
§ 1003.20   Notification by the manufacturer to the Secretary.
The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:
(a) Identification of the product or products involved;
(b) The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;
(c) The expected usage for the product if known to the manufacturer;
(d) A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard;
(e) An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard;
(f) A statement of the measures to be taken to repair such defect or to bring the product into compliance with the Federal standard;
(g) The date and circumstances under which the defect was discovered; and
(h) The identification of any trade secret information which the manufacturer desires kept confidential.
§ 1003.21   Notification by the manufacturer to affected persons.
(a) The notification to the persons specified in § 1003.10(b) shall be in writing and, in addition to other relevant information which the Secretary may require, shall include:
(1) The information prescribed by § 1003.20 (a), (d), and instructions with respect to the use of the product pending the correction of the defect;
(2) A clear evaluation in nontechnical terms of the hazards reasonably related to any defect or failure to comply; and
(3) The following statement:
The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you.
(b) The envelope containing the notice shall not contain advertising or other extraneous material, and such mailings will be made in accordance with this section.
(1) No. 10 white envelopes shall be used, and the name and address of the manufacturer shall appear in the upper left corner of the envelope.
(2) The following statement is to appear in the far left third of the envelope in the type and size indicated and in reverse printing, centered in a red rectangle 3 3/4 inches wide and 2 1/4 inches high:
(3) Envelopes with markings similar to those prescribed in this section shall not be used by manufacturers for mailings other than those required by this part.
(c) The notification shall be sent:
(1) By certified mail to purchasers of the product and to subsequent transferees.
(2) By certified mail or other more expeditious means to dealers and distributors.
(d) Where products were sold under a name other than that of the manufacturer of the product, the name of the individual or company under whose name the product was sold may be used in the notification required by this section.
§ 1003.22   Copies of communications sent to purchasers, dealers or distributors.
(a) Every manufacturer of electronic products shall furnish to the Secretary a copy of all notices, bulletins, or other communications sent to the dealers or distributors of such manufacturers or to purchasers (or subsequent transferees) of electronic products of such manufacturer regarding any defect in such product or any failure of such product to comply with an applicable Federal standard.
(b) In the event the Secretary deems the content of such notices to be insufficient to protect the public health and safety, the Secretary may require additional notice to such recipients, or may elect to make or cause to be made such notification by whatever means he deems appropriate.
§ 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.