(a) Criteria for variances. (1) Upon application by a manufacturer (including an assembler), the Director, Center for Devices and Radiological Health, Food and Drug Administration, may grant a variance from one or more provisions of any performance standard under subchapter J of this chapter for an electronic product subject to such standard when the Director determines that granting such a variance is in keeping with the purposes of Subchapter C--Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968), and:
(i) The scope of the requested variance is so limited in its applicability as not to justify an amendment to the standard, or
(ii) There is not sufficient time for the promulgation of an amendment to the standard.
(2) The issuance of the variance shall be based upon a determination that:
(i) The product utilizes an alternate means for providing radiation safety or protection equal to or greater than that provided by products meeting all requirements of the applicable standard, or
(ii) The product performs a function or is intended for a purpose which could not be performed or accomplished if required to meet the applicable standards, and suitable means for assuring radiation safety or protection are provided, or
(iii) One or more requirements of the applicable standard are not appropriate, and suitable means for assuring radiation safety or protection are provided.
(b) Applications for variances. If you are submitting an application for variances or for amendments or extensions thereof, you must submit an original and two copies to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(1) The application for variance shall include the following information:
(i) A description of the product and its intended use.
(ii) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.
(iii) A description of the manner in which it is proposed to deviate from the requirements of the applicable standard.
(iv) A description of the advantages to be derived from such deviation.
(v) An explanation of how alternate or suitable means of radiation protection will be provided.
(vi) The period of time it is desired that the variance be in effect, and, if appropriate, the number of units the applicant wishes to manufacture.
(vii) In the case of prototype or experimental equipment, the proposed location of each unit.
(viii) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application.
(ix) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the good laboratory practice regulations 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.
(xi) If the electronic product is used in a clinical investigation involving human subjects, is subject to the requirements for institutional review set forth in part 56 of this chapter, and is subject to the requirements for informed consent set forth in part 50 of this chapter, the investigation shall be conducted in compliance with such requirements.
(2) The application for amendment or extension of a variance shall include the following information:
(i) The variance number and expiration date.
(ii) The amendment or extension requested and basis for the amendment or extension.
(iii) A description of the effect of the amendment or extension on protection from radiation produced by the product.
(iv) An explanation of how alternate or suitable means of protection will be provided.
(c) Ruling on applications. (1) The Director, Center for Devices and Radiological Health, may approve or deny, in whole or in part, a requested variance or any amendment or extension thereof, and the director shall inform the applicant in writing of this action on a requested variance or amendment or extension. The written notice will state the manner in which the variance differs from the standard, the effective date and the termination date of the variance, a summary of the requirements and conditions attached to the variance, any other information that may be relevant to the application or variance, and, if appropriate, the number of units or other similar limitations for which the variance is approved. Each variance will be assigned an identifying number.
(2) The Director, Center for Devices and Radiological Health, shall amend or withdraw a variance whenever the Director determines that this action is necessary to protect the public health or otherwise is justified by this subchapter. Such action will become effective on the date specified in the written notice of the action sent to the applicant, except that it will become effective immediately upon notification to the applicant when the Director determines that such action is necessary to prevent an imminent health hazard.
(3) All applications for variances and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications will be available for public disclosure in the office of the Division of Dockets Management, except for information regarded as confidential under section 537(e) of the act.
(d) Certification of equipment covered by variance. The manufacturer of any product for which a variance is granted shall modify the tag, label, or other certification required by 1010.2 to state:
(1) That the product is in conformity with the applicable standard, except with respect to those characteristics covered by the variance;
(2) That the product is in conformity with the provisions of the variance; and
(3) The assigned number and effective date of the variance.