(a) Manufacturers of electronic products may submit to the Director a request, together with accompanying justification, for exemption from any requirements listed in table 1 of 1002.1. The request must specify each requirement from which an exemption is requested. In addition to other information that is required, the justification must contain documented evidence showing that the product or product type for which the exemption is requested does not pose a public health risk and meets at least one of the following criteria:
(1) The products cannot emit electronic product radiation in sufficient intensity or of such quality, under any conditions of operation, maintenance, service, or product failure, to be hazardous;
(2) The products are produced in small quantities;
(3) The products are used by trained individuals and are to be used by the same manufacturing corporation or for research, investigation, or training.
(4) The products are custom designed and used by trained individuals knowledgeable of the hazards; or
(5) The products are produced in such a way that the requirements are inappropriate or unnecessary.
(b) The Director may, subject to any conditions that the Director deems necessary to protect the public health, exempt manufacturers from all or part of the record and reporting requirements of this part on the basis of information submitted in accordance with paragraph (a) of this section or such other information which the Director may possess if the Director determines that such exemption is in keeping with the purposes of the Act.
(c) The Director will provide written notification of the reason for any denial. If the exemption is granted, the Director will provide written notification of:
(1) The electronic product or products for which the exemption has been granted;
(2) The requirements from which the product is exempted; and
(3) Such conditions as are deemed necessary to protect the public health and safety. Copies of exemptions shall be available upon request from the Food and Drug Administration, Center for Devices and Radiological Health, Division of Mammography Quality and Radiation Programs, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002.
(d) The Director may, on the Director's own motion, exempt certain classes of products from the reporting requirements listed in table 1 of 1002.1, provided that the Director finds that such exemption is in keeping with the purposes of the act.
(e) Manufacturers of products for which there is no applicable performance standard under parts 1020 through 1050 of this chapter and for which an investigational device exemption has been approved under 812.30 of this chapter or for which a premarket approval application has been approved in accordance with 814.44(d) of this chapter are exempt from submitting all reports listed in table 1 of 1002.1.
[60 FR 48387, Sept. 19, 1995, as amended at 72 FR 17401, Apr. 9, 2007; 75 FR 20916, Apr. 22, 2010]