Source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1003&showFR=1
Timestamp: 2013-05-19 23:34:07
Document Index: 94867974

Matched Legal Cases: ['art 803', 'art 803', 'art 803', 'art 16', 'art 58', 'art 56', 'art 50', 'art 16']

Sec. 1003.1 Applicability.
Sec. 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.
Sec. 1003.5 Effect of regulations on other laws.
Subpart B--Discovery of Defect or Failure To Comply
Sec. 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.[38 FR 28628, Oct. 15, 1973 and 49 FR 36351, Sept. 14, 1984]
Sec. 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.The manufacturer shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.(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.[38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 FR 15676, Mar. 22, 1977]
Subpart D--Exemptions From Notification Requirements
Sec. 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.
Sec. 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]