FDA 3662 Cephalometric Report

Form Approved: OMB No. 0910-0025
Expiration Date: January 31, 2017

FORM FDA 3662 (12/15)
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 and 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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paper Reduction Act (PRA) Staff
[email protected]
*Please do NOT send your completed document to this PRA Staff email address.*
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.

This guidance was written prior to the February 27, 1997 implementation of FDA’s
Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person
and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statute, regulations, or both.
This guidance will be updated in the next revision to include the standard elements of GGP’s.

More industry guidance and assistance can be found at the FDA homepage, see:
http://www.fda.gov/Radiation-EmittingProducts/ .

Send your completed report to:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
Questions about reporting and suggestions for changes to this guide may be sent to the above
address or may be discussed by calling 1-800-638-2041.

FORM FDA 3662 (12/15)

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

MARCH 1996

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Silver Spring, MD 20993

FORM FDA 3662 (12/15)

Foreword
The Office of Compliance, Center for Devices and Radiological Health (CDRH) developed this guide. This guide will
assist manufacturers¹ of electronic products which emit radiation in providing adequate reporting of radiation safety testing
and compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and
1003 specify Reporting and Notification requirements²,³.
Reports submitted on radiation safety of electronic products must follow the appropriate guide (21 CFR 1002.7). If the
report does not follow an applicable guide it must contain a sufficient justification for any deviations. 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. If a report is incomplete or inadequate CDRH may reject it and return it for completion. CDRH will not
enter a rejected report into our database. Also, a rejected report will not receive an accession number.
WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is the manufacturer’s
responsibility to certify that their products comply with all applicable standards (21 CFR 1010 - 1050), based on a testing
program in accordance with good manufacturing practices. Prior to the shipment of products in interstate commerce
21 CFR 1002 requires the manufacturer to submit the report and to comply with all applicable importation requirements
(21 CFR 1005). If there are deficiencies, we may disapprove the firm’s quality control and testing program, determine
that the product contains a radiation defect, or determine that the product fails to comply with a standard. We will notify
the manufacturer if we make such a determination. CDRH may require the manufacturer 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.
Please mail your reports to the address below (FDA can not process electronic submissions at this time). Provide the
original report with appropriate signature(s) (no facsimiles, please). Provide extra copies only if this guide specifically
requires them. Submit the report written in the English language. Translate any text that appears in a language other than
English into English in a complete and accurate manner. Keep a copy of the completed reports in your records.
We are making our reporting guides and other regulatory information available on the Internet under
http://www.fda.gov/Radiation-EmittingProducts/. No copyright exists for these guides. Reproduce these guides as needed.
If you would like to comment on the reporting guides, web site, or future electronic submissions, you may direct the comments
to the address below. If you need additional regulations for electronic products or medical devices, you should contact the
Division of Small Manufacturers, International and Consumer Assistance by telephone at 1-800-638-2041 or by facsimile at
301-847-8149.
Sincerely yours,

Lillian J. Gill
Director
Office of Compliance
E-MAIL ADDRESS: [email protected]
MAILING ADDRESS (see 21 CFR 1002.7 for further information):
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
¹

Manufacturer (see 21) CFR § 1000.3 (n)) means any person engaged in the business of manufacturing, assembling, or importing electronic products.

²

Accidental Radiation Occurrences: 21 CFR 1002.20 requires manufacturers to immediately report accidental radiation occurrences (see 21 CFR
1000.3(a) for the definition).

³

Notification: Title 21 CFR Part 1003 requires manufacturers to provide Notification of Defects or Failure to Comply. Send these notifications to the
above address.

FORM FDA 3662 (12/15)

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 (12/15)

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

Name and address of the certifying manufacturer as it should appear on the
product label

101.3

Name, address and telephone number of submitter

Email address of submitter
Identification of corresponding official

101.4

If the address listed in 101.2 above is not the manufacturing site where certification
testing is documented, then provide the name and address (below) of the location
where certification testing is documented, as it is identified on the product 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.

FORM FDA 3662 (12/15)

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 (12/15)

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 beam-limiting 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 x-ray 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 (12/15)

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 x-ray 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 (12/15)

Describe the test method used to insure that x-ray 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 (12/15)