3662 Abbreviated Report for Cephalometric Devices

Form Approved: OMB No. 0910-0025
Expiration Date: May 31, 2010

FORM FDA 3662 (7/07)
A Guide for the Submission of an Abbreviated Radiation
Safety Report on Cephalometric Devices Intended for
Diagnostic Use

Public reporting burden for this collection of information is estimated to average 5 hours per
response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Food and Drug Administration
CDRH (HFZ-342)
2094 Gaither Road
Rockville, MD 20850
An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number.

FORM FDA 3662 (7/07)

A GUIDE FOR THE SUBMISSION OF
AN ABBREVIATED RADIATION SAFETY REPORT ON
CEPHALOMETRIC DEVICES
INTENDED FOR DIAGNOSTIC USE

MARCH 1996

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20850

FORM FDA 3662 (7/07)

Foreword
This guide was developed by the Office of Compliance, Center for
Devices and Radiological Health (CDRH), to assist electronic
product manufacturers in providing adequate reporting of
radiation safety testing and compliance with performance
standards. Reporting requirements are specified in Title 21 of
the Code of Federal Regulations (CFR), Part 1002.
Reports submitted on radiation safety of electronic products
must follow the appropriate guide (21 CFR 1002.7), or contain a
justification why it was not followed. CDRH may reject an
incomplete report and return it for completion. When the report
is adequate for filing, it will be logged into the CDRH computer
system and assigned an accession number. The submitter of the
report will receive an acknowledgment letter with the accession
number we assign to the report. Please reference this accession
number in the future when providing additional information about
this model family in either a supplement or the annual report.
WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED.
It is the manufacturer's responsibility to certify that their
products comply with the applicable standard (21 CFR 1010 1050), based on a testing program in accordance with good
manufacturing practices. The manufacturer is required to submit
the report (21 CFR 1002) and to comply with all applicable
importation requirements (21 CFR 1005) prior to the shipment of
products in interstate commerce. If there are deficiencies, we
may disapprove the firm's quality control and testing program or
determine that the product contains a radiation defect or fails
to comply with a standard. We will notify the manufacturer if
we make such a determination. Then the manufacturer may be
required to cease introduction into U.S. commerce until
deficiencies are corrected, and to initiate a corrective action
program (21 CFR 1003 - 1004) for products already introduced
into commerce.
We are making our reporting guides available on the CDRH
Electronic Docket, for downloading and reproduction. They are
not copyrighted and may be reproduced as needed. The telephone
number for access to the CDRH Electronic Docket via your
personal computer's modem is 1-800-252-1366.
Please mail your reports to the address below (electronic
submissions cannot be processed yet). Provide one original

FORM FDA 3662 (7/07)

IN ENGLISH (no facsimile, please) unless specified otherwise in
the guide. Make a copy of the completed report for your
records. If you would like to comment on the reporting guides
or the electronic docket or future electronic submissions, you
may direct the comments to the same address. If you need
additional regulations for electronic products or medical
devices, contact the Division of Small Manufacturers Assistance
by telephone at 1-800-638-2041 or 301-443-6597, or by facsimile
at 301-443-8818.

Sincerely yours,

Lillian J. Gill
Director
Office of Compliance

MAILING ADDRESS:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
OFFICE OF COMPLIANCE (HFZ-307)
ATTN: ELECTRONIC PRODUCT REPORTS
2098 GAITHER ROAD
ROCKVILLE MD 20850

FORM FDA 3662 (7/07)

INTRODUCTION
This guide presents an outline for a manufacturer to follow in
preparing an abbreviated report, or abbreviated supplemental
report, for cephalometric devices intended for use with
diagnostic x-ray equipment. These certifiable components are
subject to the Performance Standard, 21 CFR 1020.30 and 1020.31.
The focus of the guide is to identify the pertinent information
required by the Food and Drug Administration for the
certification of cephalometric devices. Information submitted
will be considered toward fulfillment of the requirements of the
Radiation Control for Health and Safety Act of 1968 (Public Law
90-602).
This reporting guide is to be used as a replacement for other
previous guides that have been developed for presentation of
product (initial) report and supplemental report data. This
guide applies only to the manufacture and certification of
cephalometric devices. It can not be used for other certifiable
components.
NOTE:

FORM FDA 3662 (7/07)

All reports submitted under this abbreviated guide
must be in English.

PART 100 - IDENTIFICATION
101.0

REPORT IDENTIFICATION
Confirm that this report is submitted pursuant to
paragraph (c)(1) of section 1002.61, and state the
following:

101.1

Report type (product (initial) report or supplement to
CDRH Accession #
)

101.2

Identification of certifying manufacturer name and
address which should appear on the product label.

101.3

Name, address and telephone number of submitter and
identification of corresponding official.

101.4

If the address listed in 101.2 above is not the
manufacturing cite where certification testing is
documented, then provide the name and address of that
location. Indicate how this manufacturing site is
identified on your label.

102.0

PRODUCT IDENTIFICATION

102.1

Provide the model designation as would appear on the
component identification label, for each cephalometric
component being certified in this report.

102.2

If the model designation(s) reported above is sold under
a name other than your own, provide the model designation
and name and address of each company under whose name the
product is sold or labeled.

102.3

For each model designation listed under 102.1 and/or
102.2, provide an exact replica of all labeling completed
with the following items filled in as would be found on
the component when shipped:
(a)
(b)
(c)
(d)
(e)

102.4

certification statement;
name and address of manufacturer;
date and place of manufacture;
model designation and sample serial number; and
a drawing indicating the location of the label.

Attach the following information as appendices:
(a)
(b)

FORM FDA 3662 (7/07)

assembler's manual -- Appendix A
user's manual -- Appendix B

PART 200 - COMPONENT DESCRIPTION FOR
CEPHALOMETRIC DEVICES
This section should be completed for each cephalometric device
listed in section 102.1 of PART 100 that includes a beamlimiting device (BLD) as an integral design feature.
200.1

For each model cephalometric device, indicate the design
SID, and the image receptor size.

200.2

Describe the means for limiting and/or centering the xray field.

200.3

If a light field is used to define the perimeter of the
x-ray field, then it must meet the requirements of 21 CFR
1020.31(d)(2).

FORM FDA 3662 (7/07)

PART 300 - QUALITY CONTROL TESTING
CEPHALOMETRIC DEVICES
This section requires documentation and test data to assure that
cephalometric devices that include beam-limiting devices (BLDs)
and which function at one SID and image receptor size, meet the
requirement to limit the x-ray field at the plane of the image
receptor to dimensions no greater than those of the image
receptor, or the requirement to align the x-ray field such that
at the plane of the image receptor, the x-ray field does not
extend beyond any edge of the image receptor. When prototype
and production testing are identical, refer to production
testing.
300.1

Critical Parameters - As a result of inherent
inaccuracies of test procedures and instrumentation,
rejection limits for any test must be sufficiently
restrictive to assure compliance with the standard.

300.2

Prototype Testing

300.3

a.

Describe the test method used to insure that xray is properly aligned and centered with the
image receptor.

b.

Identify all test instruments by manufacturer and
model number.

c.

Describe the procedure for periodic calibration
of the test instruments.

d.

Provide prototype test data and rejection limits.

e.

If a light field is used to define the perimeter
of the x-ray field, describe in detail the test
method used to insure compliance with the light
field requirements for light illuminance, edge
contrast ratio, and alignment of visually defined
field.

Production Testing
a.

FORM FDA 3662 (7/07)

Describe the test method used to insure that xray is properly aligned and centered with the
image receptor.

b.

Identify all test instruments by manufacturer and
model number.

c.

Describe the procedure for periodic calibration
of the test instruments.

d.

Provide production test data and rejection
limits.

e.

If a light field is used to define the perimeter
of the x-ray field, describe in detail the test
method used to insure compliance with the light
field requirements for light illuminance, edge
contrast ratio, and alignment of visually defined
field.

FORM FDA 3662 (7/07)