[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1010.4]

[Page 573-575]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 1010.4  Variances.

    (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 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

[[Page 574]]

    (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 Dockets Management Branch (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.
    (x) [Reserved]
    (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

[[Page 575]]

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 Dockets Management Branch, except for information regarded 
as confidential under section 360A(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 Sec. 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.

[39 FR 13879, Apr. 18, 1974, as amended at 44 FR 48191, Aug. 17, 1979; 
50 FR 7518, Feb. 22, 1985; 50 FR 13565, Apr. 5, 1985; 53 FR 11254, Apr. 
6, 1988; 53 FR 52683, Dec. 29, 1988; 59 FR 14365, Mar. 28, 1994; 65 FR 
17137, Mar. 31, 2000]