[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1010]
[Page 604-610]
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
Subpart A_General Provisions
Sec.
1010.1 Scope.
1010.2 Certification.
1010.3 Identification.
1010.4 Variances.
1010.5 Exemptions for products intended for United States Government
use.
Subpart B_Alternate Test Procedures
1010.13 Special test procedures.
Subpart C_Exportation of Electronic Products
1010.20 Electronic products intended for export.
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C.
263b-263n.
Source: 38 FR 28631, Oct. 15, 1973, unless otherwise noted.
Subpart A_General Provisions
Sec. 1010.1 Scope.
The standards listed in this subchapter are prescribed pursuant to
section 358 of the Radiation Control for Health and Safety Act of 1968
(42 U.S.C. 263f) and are applicable to electronic products as specified
herein, to control electronic product radiation from such products.
Standards so prescribed are subject to amendment or revocation and
additional standards may be prescribed as are determined necessary for
the protection of the public health and safety.
[40 FR 32257, July 31, 1975]
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Sec. 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an
applicable standard is in effect under this subchapter shall furnish to
the dealer or distributor, at the time of delivery of such product, the
certification that such product conforms to all applicable standards
under this subchapter.
(b) The certification shall be in the form of a label or tag
permanently affixed to or inscribed on such product so as to be legible
and readily accessible to view when the product is fully assembled for
use, unless the applicable standard prescribes some other manner of
certification. All such labels or tags shall be in the English language.
(c) Such certification shall be based upon a test, in accordance
with the standard, of the individual article to which it is attached or
upon a testing program which is in accordance with good manufacturing
practices. The Director, Center for Devices and Radiological Health may
disapprove such a testing program on the grounds that it does not assure
the adequacy of safeguards against hazardous electronic product
radiation or that it does not assure that electronic products comply
with the standards prescribed under this subchapter.
(d) In the case of products for which it is not feasible to certify
in accordance with paragraph (b) of this section, upon application by
the manufacturer, the Director, Center for Devices and Radiological
Health may approve an alternate means by which such certification may be
provided.
[38 FR 28631, Oct. 15, 1973, as amended at 40 FR 32257, July 31, 1975;
42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988]
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Sec. 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard
under this subchapter is applicable shall set forth the information
specified in paragraphs (a)(1) and (2) of this section. This information
shall be provided in the form of a tag or label permanently affixed or
inscribed on such product so as to be legible and readily accessible to
view when the product is fully assembled for use or in such other manner
as may be prescribed in the applicable standard. Except for foreign
equivalent abbreviations as authorized in paragraph (a)(1) of this
section all such labels or tags shall be in the English language.
(1) The full name and address of the manufacturer of the product;
abbreviations such as ``Co.,'' ``Inc.,'' or their foreign equivalents
and the first and middle initials of individuals may be used. Where
products are sold under a name other than that of the manufacturer of
the product, the full name and address of the individual or company
under whose name the product was sold may be set forth, provided such
individual or company has previously suppled the Director, Center for
Devices and Radiological Health with sufficient information to identify
the manufacturer of the product.
(2) The place and month and year of manufacture:
(i) The place of manufacture may be expressed in code provided the
manufacturer has previously supplied the Director, Center for Devices
and Radiological Health with the key to such code.
(ii) The month and year of manufacture shall be provided clearly and
legibly, without abbreviation, and with the year shown as a four-digit
number as follows:
Manufactured: (Insert Month and Year of Manufacture.)
(b) In the case of products for which it is not feasible to affix
identification labeling in accordance with paragraph (a) of this
section, upon application by the manufacturer, the Director, Center for
Devices and Radiological Health may approve an alternate means by which
such identification may be provided.
(c) Every manufacturer of an electronic product to which a standard
under this subchapter is applicable shall provide to the Director,
Center for Devices and Radiological Health a list identifying each brand
name which is applied to the product together with
the full name and address of the individual or company for whom each
product so branded is manufactured.
[40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977; 53
FR 11254, Apr. 6, 1988]
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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
(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.
(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 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 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]
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Sec. 1010.5 Exemptions for products intended for United States
Government use.
(a) Criteria for exemption. Upon application by a manufacturer
(including assembler) or by a U.S. department or agency, the Director,
Center for Devices and Radiological Health, Food and Drug
Administration, may grant an exemption from any performance standard
under subchapter J of this chapter for an electronic product, or class
of products, otherwise subject to such standard when he determines that
such electronic product or class is intended for use by departments or
agencies of the United States and meets the criteria set forth in
paragraph (a) (1) or (2) of this section.
(1) The procuring agency shall prescribe procurement specifications
for the product or class of products governing emissions of electronic
product radiation, and the product or class shall be of a type used
solely or predominantly by a department or agency of the United States.
(2) The product or class of products is intended for research,
investigations, studies, demonstration, or training, or for reasons of
national security.
(b) Consultation between the procuring agency and the Food and Drug
Administration. The United States department or agency that intends to
procure or manufacture a product or class of products subject to
electronic product radiation safety standards contained in this
subchapter should consult with the Center for Devices and Radiological
Health, Food and Drug Administration, whenever it is anticipated that
the specifications for the product or class must deviate from, or be in
conflict with, such applicable standards. Such consultation should occur
as early as possible during development of such specifications. The
department or agency should include in the specifications all
requirements of such standards that are not in conflict with, or are not
inappropriate for, the special or unique uses for which the product is
intended. The procuring agency should indicate to the Center for Devices
and Radiological Health if it desires to be notified of the approval,
amendment, or withdrawal of the exemption.
(c) Application for exemption. If you are submitting an application
for exemption, or for amendment or extension 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. For an exemption under the criteria prescribed in paragraph
(a)(1) of this section, the application shall include the information
prescribed in paragraphs (c)(1) through (c)(13) of this section. For an
exemption under the criteria prescribed in paragraph (a)(2) of this
section, the application shall include the information prescribed in
paragraphs (c)(3) through (c)(13) of this section. An application for
exemption, or for amendment or extension thereof, and correspondence
relating to such application shall be made available for public
disclosure in the Division of Dockets Management, except for
confidential or proprietary information submitted in accordance with
part 20 of this chapter. Information classified for reasons of national
security shall not be included in the application. Except as indicated
in this paragraph, the application for exemption shall include the
following:
(1) The procurement specifications for the product or class of
products that govern emissions of electronic product radiation.
(2) Evidence that the product or class of products is of a type used
solely or predominantly by departments or agencies of the United States.
(3) Evidence that such product or class of products is intended for
use by a department or agency of the United States.
(4) A description of the product or class of products and its
intended use.
(5) An explanation of how compliance with the applicable standard
would restrict or be inappropriate for this intended use.
(6) A description of the manner in which it is proposed that the
product or class of products shall deviate from the requirements of the
applicable standard.
(7) An explanation of the advantages to be derived from such
deviation.
(8) An explanation of how means of radiation protection will be
provided where the product or class of products deviates from the
requirements of the applicable standard.
(9) The period of time it is desired that the exemption be in
effect, and, if appropriate, the number of units to be manufactured
under the exemption.
(10) The name, address, and telephone number of the manufacturer or
his agent.
(11) The name, address, and telephone number of the appropriate
office of the United States department or agency purchasing the product
or class of products.
(12) Such other information required by regulation or by the
Director, Center for Devices and Radiological Health, to evaluate and
act on the application. Where such information includes nonclinical
laboratory studies, the information shall include, with respect to each
nonclinical study, either a statement that each 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 statement that describes in detail all differences between the
practices used in the study and those required in the regulations. When
such information includes clinical investigations involving human
subjects, the information 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 Sec. 56.104 or Sec. 56.105 and a
statement that each investigation was conducted in compliance with the
requirements set forth in part 50 of this chapter.
(13) With respect to each nonclinical laboratory study contained in
the application, 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.
(d) Amendment or extension of an exemption. An exemption is granted
on the basis of the information contained in the orginal applicaion.
Therefore, if changes are needed in the radiation safety specifications
for the product, or its use, or related radiation control procedures
such that the information in the original application would no longer be
correct with respect to radiation safety, the applicant shall submit in
advance of such changes a request for an amendment to the exemption. He
also shall submit a request for extension of the exemption, if needed,
at least 60 days before the expiration date. The application for
amendment or extension of an exemption shall include the following
information:
(1) The exemption number and expiration date.
(2) The amendment or extension requested and basis for the amendment
or extension.
(3) If the radiation safety specifications for the product or class
of products or the product's or class of products' use or related
radiation control procedures differ from the description provided in the
original application, a description of such changes.
(e) Ruling on an application. (1) The Director, Center for Devices
and Radiological Health, may grant an exemption including in the written
notice of exemption such conditions or terms as may be necessary to
protect the public health and safety and shall notify the applicant in
writing of his action. The conditions or terms of the exemption may
include specifications concerning the manufacture, use, control, and
disposal of the excess or surplus exempted product of class of products
as provided in the Code of Federal Regulations, title 41, subtitle C.
Each exemption will be assigned an identifying number.
(2) The Director, Center for Devices and Radiological Health, shall
amend or withdraw an exemption whenever he determines that such action
is necessary to protect the public health or otherwise is justified by
provisions of the act or this subchapter. Such action shall become
effective on the date specified in the written notice of the action sent
to the applicant, except that it shall become effective immediately when
the Director determines that it is necessary to prevent an imminent
health hazard.
(f) Identification of equipment covered by exemption. The
manufacturer of any product for which an exemption is granted shall
provide the following identification in the form of a tag or label
permanently affixed or inscribed on such product so as to be legible and
readily accessible to view when the product is fully assembled for use
or in such other manner as may be prescribed in the exemption:
Caution
This electronic product has been exempted from Food and Drug
Administration radiation safety performance standards prescribed in the
Code of Federal Regulations, title 21, chapter I, subchapter J, pursuant
to Exemption No. ------, granted on --------------
[42 FR 44229, Sept. 2, 1977; 42 FR 61257, Dec. 2, 1977, as amended at 44
FR 17657, Mar. 23, 1979; 46 FR 8460, 8958, Jan. 27, 1981; 50 FR 7518,
Feb. 22, 1985; 50 FR 13564, Apr. 5, 1985; 53 FR 11254, Apr. 6, 1988; 59
FR 14365, Mar. 28, 1994; 65 FR 17138, Mar. 31, 2000]
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Subpart B_Alternate Test Procedures
Sec. 1010.13 Special test procedures.
The Director, Center for Devices and Radiological Health, may, on
the basis of a written application by a manufacturer, authorize test
programs other than those set forth in the standards under this
subchapter for an electronic product if he determines that such products
are not susceptible to satisfactory testing by the procedures set forth
in the standard and that the alternative test procedures assure
compliance with the standard.
[40 FR 32257, July 31, 1975, as amended at 53 FR 11254, Apr. 6, 1988]
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Subpart C_Exportation of Electronic Products
Sec. 1010.20 Electronic products intended for export.
The performance standards prescribed in this subchapter shall not
apply to any electronic product which is intended solely for export if:
(a) Such product and the outside of any shipping container used in
the export of such product are labeled or tagged to show that such
product is intended for export, and
(b) Such product meets all the applicable requirements of the
country to which such product is intended for export.
[40 FR 32257, July 31, 1975]
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