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Anticancer Properties of Ru and Os Half-Sandwich Complexes of N,S Bidentate Schiff Base Ligands Derived from Phenylthiocarbamide.
Pt. 1002
Diagnostic and nondestructive
equipment.
Ranging and detection equipment.
21 CFR Ch. I (4–1–25 Edition)
testing
§ 1002.1 Applicability.
PART 1002—RECORDS AND
REPORTS
Subpart A—General Provisions
Sec.
1002.1 Applicability.
1002.2 [Reserved]
1002.3 Notification to user of performance
and technical data.
1002.4 Confidentiality of information.
1002.7 Submission of data and reports.
Subpart B—Required Manufacturers’
Reports for Listed Electronic Products
1002.10
1002.11
1002.12
1002.13
Subpart A—General Provisions
Product reports.
Supplemental reports.
Abbreviated reports.
Annual reports.
Subpart C—Manufacturers’ Reports on
Accidental Radiation Occurrences
1002.20 Reporting of accidental radiation occurrences.
Subpart D—Manufacturers’ Records
1002.30 Records to be maintained by manufacturers.
1002.31 Preservation and inspection of
records.
Subpart E—Dealer and Distributor Records
1002.40 Records to be obtained by dealers
and distributors.
1002.41 Disposition of records obtained by
dealers and distributors.
1002.42 Confidentiality of records furnished
by dealers and distributors.
Subpart F—Exemptions From Records and
Reports Requirements
1002.50 Special exemptions.
1002.51 Exemptions for manufacturers of
products intended for the U.S. Government.
AUTHORITY: 21 U.S.C. 352, 360, 360i, 360j,
360hh–360ss, 371, 374.
SOURCE: 38 FR 28625, Oct. 15, 1973, unless
otherwise noted.
The provisions of this part are applicable as follows:
(a) All manufacturers of electronic
products are subject to § 1002.20.
(b) Manufacturers, dealers, and distributors of electronic products are
subject to the provisions of part 1002 as
set forth in table 1 of this section, unless excluded by paragraph (c) of this
section, or unless an exemption has
been granted under § 1002.50 or § 1002.51.
(c) The requirements of part 1002 as
specified in table 1 of this section are
not applicable to:
(1) Manufacturers of electronic products intended solely for export if such
product is labeled or tagged to show
that the product meets all the applicable requirements of the country to
which such product is intended for export.
(2) Manufacturers of electronic products listed in table 1 of this section if
such product is sold exclusively to
other manufacturers for use as components of electronic products to be sold
to purchasers, with the exception that
the provisions are applicable to those
manufacturers certifying components
of diagnostic x-ray systems pursuant
to provisions of § 1020.30(c) of this chapter.
(3) Manufacturers of electronic products that are intended for use by the
U.S. Government and whose function
or design cannot be divulged by the
manufacturer for reasons of national
security, as evidenced by government
security classification.
(4) Assemblers of diagnostic x-ray
equipment subject to the provisions of
§ 1020.30(d) of this chapter, provided the
assembler has submitted the report required by § 1020.30(d)(1) or (d)(2) of this
chapter and retains a copy of such report for a period of 5 years from its
date.
888
Manufacturer
Products
889
Product
reports
1002.10
Supplemental
reports
1002.11
Abbreviated
reports
1002.12
Annual
reports
1002.13
Test
records
1002.30(a) 1
Distribution
records
1002.30(b) 2
Distribution
records
1002.40 and
1002.41
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§ 1002.1
DIAGNOSTIC X-RAY 3 (1020.30, 1020.31, 1020.32,
1020.33):
Computed tomography .............................................
X-ray system 4 ..........................................................
Tube housing assembly ...........................................
X-ray control .............................................................
X-ray high voltage generator ...................................
X-ray table or cradle ................................................
X-ray film changer ....................................................
Vertical cassette holders mounted in a fixed location and cassette holders with front panels .........
Beam-limiting devices ..............................................
Spot-film devices and image intensifiers manufactured after April 26, 1977 .....................................
Cephalometric devices manufactured after February 25, 1978 ......................................................
Image receptor support devices for mammographic
X-ray systems manufactured after September 5,
1978 ......................................................................
CABINET X RAY (1020.40):
Baggage inspection ..................................................
Other ........................................................................
PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET X-RAY:
Medical .....................................................................
Analytical ..................................................................
Industrial ...................................................................
TELEVISION PRODUCTS (1020.10):
<0.1 milliroentgen per hour (mR/hr) IRLC 5 .............
≥0.1mR/hr IRLC 5 .....................................................
MICROWAVE/RF:
MW ovens (1030.10) ................................................
MW diathermy ..........................................................
Dealer &
distributor
Food and Drug Administration, HHS
TABLE 1 TO § 1002.1—RECORD AND REPORTING REQUIREMENTS BY PRODUCT
Manufacturer
Products
890
Product
reports
1002.10
Supplemental
reports
1002.11
Abbreviated
reports
1002.12
Annual
reports
1002.13
Test
records
1002.30(a) 1
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X
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X
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X
X
Distribution
records
1002.30(b) 2
Distribution
records
1002.40 and
1002.41
....................
1 However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer’s compliance testing program is retained.
2 The requirement includes §§ 1002.31 and 1002.42, if applicable.
3 Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see § 1020.30(d)(1)–(3) of this chapter.
4 Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in § 1020.30(c) of this chapter.
5 Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (§ 1020.10(c)(3)(iii)) of this chapter.
6 Annual report is for production status information only.
7 Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.
8 Manufacturers are exempt from product reports (§ 1002.10) and abbreviated reports (§ 1002.12), except the first product or abbreviated report for each category of: television products; microwave ovens; and products that are Class I laser under any condition of operation, maintenance, service, or failure (e.g., Class I
optical disc products, laser printers).
9 Manufacturers that incorporate a certified laser system meeting the conditions of 21 CFR 1010.2(e) are considered distributors of the certified laser and only
subject to the applicable distribution recordkeeping requirements under §§ 1002.40 and 1002.41 for the certified products.
21 CFR Ch. I (4–1–25 Edition)
MW heating, drying, security systems .....................
RF sealers, electromagnetic induction and heating
equipment, dielectric heaters (2–500 megahertz)
OPTICAL:
Laser products (1040.10, 1040.11) ..........................
Class I lasers and products containing such lasers 7,9 ..................................................................
Class I laser products containing class IIa, II, IIIa,
lasers 7,9 ...............................................................
Class IIa, II, IIIa lasers and products other than
class I products containing such lasers 79 ...........
Class IIIb and IV lasers and products containing
such lasers 7 .........................................................
SUNLAMP PRODUCTS (1040.20):
Lamps only ...............................................................
Sunlamp products ....................................................
Mercury vapor lamps (1040.30) ...............................
R lamps and T lamps ...............................................
Dealer &
distributor
§ 1002.1
TABLE 1 TO § 1002.1—RECORD AND REPORTING REQUIREMENTS BY PRODUCT—Continued
Food and Drug Administration, HHS
§ 1002.10
[60 FR 48382, Sept. 19, 1995; 61 FR 13423, Mar. 27, 1996, as amended at 88 FR 3652, Jan. 20, 2023]
§ 1002.2
[Reserved]
§ 1002.3 Notification to user of performance and technical data.
The Director and Deputy Director of
the Center for Devices and Radiological Health, as authorized under delegated authority, may require a manufacturer of a radiation emitting electronic product to provide to the ultimate purchaser, at the time of original
purchase, such performance data and
other technical data related to safety
of the product as the Director or Deputy Director finds necessary.
[69 FR 17292, Apr. 2, 2004]
§ 1002.4 Confidentiality of information.
The Secretary or his representative
shall not disclose any information reported to or otherwise obtained by
him, pursuant to this part, which concerns or relates to a trade secret or
other matter referred to in section 1905
of title 18 of the United States Code,
except that such information may be
disclosed to other officers or employees
of the Department and of the other
agencies concerned with carrying out
the requirements of the Act. Nothing
in this section shall authorize the
withholding of information by the Secretary, or by any officers or employees
under his control, from the duly authorized committees of the Congress.
§ 1002.7 Submission of data and reports.
All submissions such as reports, test
data, product descriptions, and other
information required by this part, or
voluntarily submitted to the Director,
Center for Devices and Radiological
Health, shall be filed with the number
of copies as prescribed by the Director,
Center for Devices and Radiological
Health, and shall be signed by the person making the submission. The submissions required by this part shall be
addressed to the Food and Drug Administration, Center for Devices and Radiological Health, ATTN: Electronic
Product Reports, Document Mail Center, 10903 New Hampshire Ave., Bldg.
66, rm. G609, Silver Spring, MD 20993–
0002.
(a) In addition to the requirements of
this part, all material submitted to the
Director, Center for Devices and Radiological Health, shall be submitted pursuant to the provisions of part 20—Public Information, of this chapter.
(b) Where guides or instructions have
been issued by the Director for the submission of material required by this
part, such as test data, product reports,
abbreviated reports, supplemental reports, and annual reports, the material
submitted shall conform to the applicable reporting guides or instructions.
Where it is not feasible or where it
would not be appropriate to conform to
any portion of a prescribed reporting
guide or instruction, an alternate format for providing the information requested by that portion of the guide or
instruction may be used provided the
submitter of such information submits
adequate explanation and justification
for use of an alternate format. If the
Director, Center for Devices and Radiological Health, determines that such
justification is inadequate and that it
is feasible or appropriate to conform to
the prescribed reporting guide or instruction, he may require resubmission
of the information in conformance with
the reporting guide or instruction.
(c) Where the submission of quality
control and testing information is common to more than one model, or model
family of the same product category, a
‘‘common aspects report’’ consolidating similar information may be provided, if applicable.
[42 FR 18062, Apr. 5, 1977, as amended at 53
FR 11254, Apr. 6, 1988; 60 FR 48385, Sept. 19,
1995; 72 FR 17400, Apr. 9, 2007; 75 FR 20916,
Apr. 22, 2010]
Subpart B—Required Manufacturers’ Reports for Listed Electronic Products
SOURCE: 60 FR 48386, Sept. 19, 1995, unless
otherwise noted.
§ 1002.10 Product reports.
Every manufacturer of a product or
component requiring a product report
as set forth in table 1 of § 1002.1 shall
submit a product report to the Food
891
§ 1002.11
21 CFR Ch. I (4–1–25 Edition)
and Drug Administration, Center for
Devices
and
Radiological
Health,
ATTN: Electronic Product Reports,
Document Mail Center, 10903 New
Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993–0002, prior to the
introduction of such product into commerce. The report shall be distinctly
marked ‘‘Radiation Safety Product Report of (name of manufacturer)’’ and
shall:
(a) Identify which listed product is
being reported.
(b) Identify each model of the listed
product together with sufficient information concerning the manufacturer’s
code or other system of labeling to enable the Director to determine the
place of manufacture.
(c) Include information on all components and accessories provided in, on,
or with the listed product that may affect the quantity, quality, or direction
of the radiation emissions.
(d) Describe the function, operational
characteristics
affecting
radiation
emissions, and intended and known
uses of each model of the listed product.
(e) State the standard or design specifications, if any, for each model with
respect to electronic product radiation
safety. Reference may be made to a
Federal standard, if applicable.
(f) For each model, describe the physical or electrical characteristics, such
as shielding or electronic circuitry, incorporated into the product in order to
meet the standards or specifications reported pursuant to paragraph (e) of
this section.
(g) Describe the methods and procedures employed, if any, in testing and
measuring each model with respect to
electronic product radiation safety, including the control of unnecessary, secondary, or leakage electronic product
radiation, the applicable quality control procedures used for each model,
and the basis for selecting such testing
and quality control procedures.
(h) For those products which may
produce increased radiation with aging,
describe the methods and procedures
used, and frequency of testing of each
model for durability and stability with
respect to electronic product radiation
safety. Include the basis for selecting
such methods and procedures, or for de-
termining that such testing and quality control procedures are not necessary.
(i) Provide sufficient results of the
testing, measuring, and quality control
procedures described in accordance
with paragraphs (g) and (h) of this section to enable the Director to determine the effectiveness of those test
methods and procedures.
(j) Report for each model all warning
signs, labels, and instructions for installation, operation, and use that relate to electronic product radiation
safety.
(k) Provide, upon request, such other
information as the Director may reasonably require to enable him/her to
determine whether the manufacturer
has acted or is acting in compliance
with the Act and any standards prescribed thereunder, and to enable the
Director to carry out the purposes of
the Act.
[60 FR 48386, Sept. 19, 1995, as amended at 72
FR 17400, Apr. 9, 2007; 75 FR 20916, Apr. 22,
2010]
§ 1002.11 Supplemental reports.
Prior to the introduction into commerce of a new or modified model within a model or chassis family of a product listed in table 1 of § 1002.1 for which
a report under § 1002.10 is required, each
manufacturer shall submit a report
with respect to such new or modified
model describing any changes in the information previously submitted in the
product report. Reports will be required for changes that:
(a) Affect actual or potential radiation emission.
(b) Affect the manner of compliance
with a standard or manner of testing
for radiation safety.
§ 1002.12 Abbreviated reports.
Manufacturers of products requiring
abbreviated reports as specified in
table 1 of § 1002.1 shall submit, prior to
the introduction of such product, a report distinctly marked ‘‘Radiation
Safety Abbreviated Report’’ which
shall include:
(a) Firm and model identification.
(b) A brief description of operational
characteristics that affect radiation
emissions, transmission, or leakage or
that control exposure.
892
Food and Drug Administration, HHS
§ 1002.20
(c) A list of applications or uses.
(d) Radiation emission, transmission,
or leakage levels.
(e) If necessary, additional information as may be requested to determine
compliance with the Act and this part.
§ 1002.13
Annual reports.
(a) Every manufacturer of products
requiring an annual report as specified
in table 1 of § 1002.1 shall submit an annual report summarizing the contents
of the records required to be maintained by § 1002.30(a) and providing the
volume of products produced, sold, or
installed.
(b) Reports are due annually by September 1. Such reports shall cover the
12-month period ending on June 30 preceding the due date of the report.
[60 FR 48386, Sept. 19, 1995, as amended at 88
FR 3653, Jan. 20, 2023]
Subpart C—Manufacturers’ Reports on Accidental Radiation
Occurrences
§ 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable grounds
for suspecting that such an incident
has occurred, report to the Director,
Center for Devices and Radiological
Health, all accidental radiation occurrences reported to or otherwise known
to the manufacturer and arising from
the manufacturing, testing, or use of
any product introduced or intended to
be introduced into commerce by such
manufacturer. Reasonable grounds include, but are not necessarily limited
to, professional, scientific, or medical
facts or opinions documented or otherwise, that conclude or lead to the conclusion that such an incident has occurred.
(b) Such reports shall be submitted
either electronically through Center
for Devices and Radiological Health
eSubmitter or addressed to the Food
and Drug Administration, Center for
Devices
and
Radiological
Health,
ATTN: Accidental Radiation Occurrence Reports, Document Mail Center,
10903 New Hampshire Ave., Bldg. 66, rm.
G609, Silver Spring, MD 20993–0002, and
the reports and their envelopes shall be
distinctly marked ‘‘Report on 1002.20’’
and shall contain all of the following
information where known to the manufacturer:
(1) The nature of the accidental radiation occurrence;
(2) The location at which the accidental radiation occurrence occurred;
(3) The manufacturer, type, and
model number of the electronic product or products involved;
(4) The circumstances surrounding
the accidental radiation occurrence,
including causes;
(5) The number of persons involved,
adversely affected, or exposed during
the accidental radiation occurrence,
the nature and magnitude of their exposure and/or injuries and, if requested
by the Director, Center for Devices and
Radiological Health, the names of the
persons involved;
(6) The actions, if any, which may
have been taken by the manufacturer,
to control, correct, or eliminate the
causes and to prevent reoccurrence;
and
(7) Any other pertinent information
with respect to the accidental radiation occurrence.
(c) If a manufacturer:
(1) Is required to report to the Director under paragraph (a) of this section
and also is required to report under
part 803 of this chapter, the manufacturer shall report in accordance with
part 803; or
(2) Is required to report to the Director under paragraph (a) of this section
and is not required to report under part
803 of this chapter, the manufacturer
shall:
(i) Immediately report incidents associated with a death or serious injury
in accordance with paragraphs (a) and
(b) of this section; and
(ii) Either immediately report incidents not associated with a death or serious injury individually or compile
such incidents for submission in a
quarterly summary report with tracking and trending analysis of that data
in accordance with paragraphs (a) and
(b) of this section. The quarterly report
must cover information required under
paragraphs (b)(1) through (7) of this
section for each occurrence were
known to the manufacturer. Occurrences may be grouped to identify the
893
§ 1002.30
21 CFR Ch. I (4–1–25 Edition)
most common circumstances and potential cause(s), including but not limited to, design changes, manufacturing,
or user. Planned mitigation(s) with an
assessment of effectiveness, or a justification for why mitigation is not
necessary, must be associated with
each occurrence or grouping of similar
occurrences. A manufacturer need not
file a separate report under this section
if an incident involving an accidental
radiation occurrence is associated with
a defect or noncompliance and is reported pursuant to § 1003.10 of this
chapter.
maintain the following records with respect to such products:
(1) A record of the manufacturer’s
distribution of products in a form
which will enable the tracing of specific products or production lots to distributors or to dealers in those instances in which the manufacturer distributes directly to dealers.
(2) Records received from dealers or
distributors pursuant to § 1002.41.
[38 FR 28625, Oct. 15, 1973, as amended at 60
FR 48386, Sept. 19, 1995; 75 FR 16352, Apr. 1,
2010]
§ 1002.31 Preservation and inspection
of records.
[88 FR 3653, Jan. 20, 2023]
Subpart D—Manufacturers’
Records
§ 1002.30 Records to be maintained by
manufacturers.
(a) Manufacturers of products listed
under table 1 of § 1002.1 shall establish
and maintain the following records
with respect to such products:
(1) Description of the quality control
procedures with respect to electronic
product radiation safety.
(2) Records of the results of tests for
electronic product radiation safety, including the control of unnecessary, secondary or leakage electronic product
radiation, the methods, devices, and
procedures used in such tests, and the
basis for selecting such methods, devices, and procedures.
(3) For those products displaying
aging effects which may increase electronic product radiation emission,
records of the results of tests for durability and stability of the product, and
the basis for selecting these tests.
(4) Copies of all written communications between the manufacturer and
dealers, distributors, and purchasers
concerning radiation safety including
complaints, investigations, instructions, or explanations affecting the
use, repair, adjustment, maintenance,
or testing of the listed product.
(5) Data on production and sales volume levels if available.
(b) In addition to the records required by paragraph (a) of this section,
manufacturers of products listed in
table 1 of § 1002.1 shall establish and
(a) Every manufacturer required to
maintain records pursuant to this part,
including records received pursuant to
§ 1002.41, shall preserve such records for
a period of 5 years from the date of the
record.
(b) Upon reasonable notice by an officer or employee duly designated by the
Department, manufacturers shall permit such officer or employee to inspect
appropriate books, records, papers, and
documents as are relevant to determining whether the manufacturer has
acted or is acting in compliance with
Federal standards.
(c) Upon request of the Director, Center for Devices and Radiological
Health, a manufacturer of products
listed in table 1 of § 1002.1 shall submit
to the Director, copies of the records
required to be maintained by paragraph (b) of § 1002.30.
[38 FR 28625, Oct. 15, 1973, as amended at 53
FR 11254, Apr. 6, 1988; 60 FR 48386, Sept. 19,
1995]
Subpart E—Dealer and Distributor
Records
§ 1002.40 Records to be obtained by
dealers and distributors.
(a) Dealers and distributors of electronic products for which there are performance standards and for which the
retail price is $50 or more shall obtain
such information as is necessary to
identify and locate first purchasers if
the product is subject to this section
by virtue of table 1 of § 1002.1.
(b) Such information shall include:
894
Food and Drug Administration, HHS
§ 1002.50
(1) The name and mailing address of
the distributor, dealer, or purchaser to
whom the product was transferred.
(2) Identification and brand name of
the product.
(3) Model number and serial or other
identification number of the product.
(4) Date of sale, award, or lease.
(c) The information obtained pursuant to this section shall be forwarded
immediately to the appropriate manufacturer of the electronic product, or
preserved as prescribed in § 1002.41.
[38 FR 28625, Oct. 15, 1973, as amended at 42
FR 18063, Apr. 5, 1977; 60 FR 48386, Sept. 19,
1995]
§ 1002.41 Disposition of records obtained by dealers and distributors.
(a) Information obtained by dealers
and distributors pursuant to § 1002.40
shall immediately be forwarded to the
appropriate manufacturer unless:
(1) The dealer or distributor elects to
hold and preserve such information and
to immediately furnish it to the manufacturer when advised by the manufacturer or the Director, Center for Devices and Radiological Health, that
such information is required for purposes of section 535 of the Act; and
(2) The dealer or distributor, upon
making the election under paragraph
(a)(1) of this section, promptly notifies
the manufacturer of such election;
such notification shall be in writing
and shall identify the dealer or distributor and the electronic product or
products for which the information is
being accumulated and preserved.
(b) Every dealer or distributor who
elects to hold and preserve information
required pursuant to § 1002.40 shall preserve the information for a period of 5
years from the date of the sale, award,
or lease of the product, or until the
dealer or distributor discontinues dealing in, or distributing the product,
whichever is sooner. If the dealer or
distributor discontinues dealing in, or
distributing the product, such information as obtained pursuant to § 1002.40
shall be furnished at that time, or before, to the manufacturer of the product.
[38 FR 28625, Oct. 15, 1973, as amended at 42
FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6,
1988; 75 FR 16352, Apr. 1, 2010]
§ 1002.42 Confidentiality of records
furnished by dealers and distributors.
All information furnished to manufacturers by dealers and distributors
pursuant to this part shall be treated
by such manufacturers as confidential
information which may be used only as
necessary to notify persons pursuant to
section 535 of the Act.
[75 FR 16353, Apr. 1, 2010]
Subpart
F—Exemptions
From
Records and Reports Requirements
§ 1002.50 Special exemptions.
(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
895
§ 1002.51
21 CFR Ch. I (4–1–25 Edition)
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
Standards, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 3621, 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; 85 FR 18444, Apr. 2, 2020]
§ 1002.51 Exemptions for manufacturers of products intended for the
U.S. Government.
Upon application therefor by the
manufacturer, the Director, Center for
Devices and Radiological Health, may
exempt from the provisions of this part
a manufacturer of any electronic product intended for use by departments or
agencies of the United States provided
such department or agency has prescribed
procurement
specifications
governing emissions of electronic prod-
uct radiation and provided further that
such product is of a type used solely or
predominantly by departments or
agencies of the United States.
[38 FR 28625, Oct. 15, 1973, as amended at 53
FR 11254, Apr. 6, 1988]
PART 1003—NOTIFICATION OF
DEFECTS OR FAILURE TO COMPLY
Subpart A—General Provisions
Sec.
1003.1
1003.2
1003.5
Applicability.
Defect in an electronic product.
Effect of regulations on other laws.
Subpart B—Discovery of Defect or Failure
To Comply
1003.10 Discovery of defect or failure of compliance by manufacturer; notice requirements.
1003.11 Determination by Secretary that
product fails to comply or has a defect.
Subpart C—Notification
1003.20 Notification by the manufacturer to
the Secretary.
1003.21 Notification by the manufacturer to
affected persons.
1003.22 Copies of communications sent to
purchasers, dealers, or distributors.
Subpart D—Exemptions from Notification
Requirements
1003.30 Application for exemption from notification requirements.
1003.31 Granting the exemption.
AUTHORITY: 21 U.S.C. 360hh–360ss.
SOURCE: 38 FR 28628, Oct. 15, 1973, unless
otherwise noted.
Subpart A—General Provisions
§ 1003.1 Applicability.
The provisions of this part are applicable to electronic products which were
manufactured after October 18, 1968.
§ 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
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