FDA 3801 Guide for Preparing Initial Reports and Model Change Rep

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

FORM FDA 3801 (6/14)
Guide for Preparing Initial Reports and Model Change
Reports on Medical Ultraviolet Lamps and
Products Containing Such Lamps

Public reporting burden for this collection of information is estimated to average 24 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.

FDA 3801 (6/14)

HHS Publication FDA 89-8275

Guide for Preparing Initial Reports and
Model Change Reports
on Medical Ultraviolet Lamps and
Products Containing Such Lamps
(21 CFR 1002.10 and 1002.12)

Compiled by
Office of Compliance and Surveillance

April 1989

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Center for Devices and Radiological Health
Silver Spring, Maryland 20993

FDA 3801 (6/14)

HHS Publication FDA 89-8275

FOREWORD
In October 1982, the Food and Drug Administration established the Center for Devices
and Radiological Health (CDRH) by merging the Bureau of Medical Devices and the Bureau
of Radiological Health.
The Center develops and implements national programs to protect the public health
in the fields of medical devices and radiological health. These programs are intended to
assure the safety, effectiveness and proper labeling of medical devices, to control unnecessary human exposure to potentially hazardous ionizing and nonionizing radiation, and to
ensure the safe, efficacious use of such radiation.
The Center publishes the results of its work in scientific journals and in its own technical reports. These reports provide a mechanism for disseminating results of CDRH and
contractor projects. They are sold by the Government Printing Office and/or the National
Technical Information Service.
Also, CDRH technical reports in radiological health are made available to the World
Health Organization (WHO) under a memorandum of agreement between WHO and the
Department of Health and Human Services. Three WHO Collaborating Centers, established under the Bureau of Radiological Health, continue to function under CDRH:
WHO Collaborating Center for Standardization of Protection Against Nonionizing
Radiations;
WHO Collaborating Center for Training and General Tasks in Radiation Medicine;
and
WHO Collaborating Center for Nuclear Medicine.
We welcome your comments and requests for further information.

John C. Villforth
Director
Center for Devices and
Radiological Health

FDA 3801 (6/14)

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PREFACE
Manufacturers of products subject to the Radiation Control for Health and Safety Act
of 1968 are required to furnish various reports to the Center for Devices and Radiological
Health. This guide is for use by manufacturers of medical ultraviolet lamps and products
intended to incorporate these lamps.
The reporting and recordkeeping requirements are specified in Part 1002, Title 21
CFR Chapter I, Subchapter J. Section 1002.10 of the Regulations requires the submission of an initial and model change report for products listed in Section 1002.61(a)(4). All
initial and model change reports must be submitted in accordance with Section 1002.10
and 1002.12, prior to the introduction of the product into U.S. commerce. (This includes
products imported into the U.S.)
Section 1002.7 requires that reports conform to the organization and item enumeration of the guide to ensure the inclusion of the information requested. This will facilitate
review and minimize followup correspondence.

Ann B. Holt
Acting Director
Office of Compliance and Surveillance

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CONTENTS
Page
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

i

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ii

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

Part 1. Manufacturer, Report Type, and Model Identification . . . . . . . . . . . .

3

Part 2. Medical Ultraviolet Product Description . . . . . . . . . . . . . . . . . . . . . . . .

5

Part 3. Description of Emission Characteristics . . . . . . . . . . . . . . . . . . . . . . . .

9

Part 4. Lamp Emission Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

Part 5. Quality Control Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

Part 6. Life and Reliability Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12

Appendix: Spectroradiometric Measurements and Testing Procedures . . . . . .

13

FDA 3801 (6/14)

iii

GUIDE FOR PREPARING INITIAL REPORTS AND MODEL CHANGE REPORTS
ON MEDICAL ULTRAVIOLET LAMPS
AND PRODUCTS CONTAINING SUCH LAMPS
(21 CFR 1002.10 and 1002.12)
INTRODUCTION
This guide has been prepared to assist manufacturers of medical ultraviolet lamps
and products intended to incorporate these lamps in the preparation of initial and model
change reports. These reports are required if such products are intended for the irradiation
of any part of the living human body by light of wavelength in air less than 320 nanometers
to perform a diagnostic or therapeutic function. The intended use of the product for the functions mentioned above is determined by the labeling statements (including advertisements and
product description) by the manufacturer, and from an analysis of the design and use of the
product.
An initial report is required for each model bearing a separate model number. If there
is a model series and the different models in that series have minor differences which do
not in any way alter the radiation safety characteristics, a complete report on one of the
models followed by supplemental reports on the others will be adequate. Supplemental
reports should respond to the appropriate parts of the guideline. Where there is no change
from a prior report this fact may be so stated. Report the changes in detail and reference
the number of the affected item. However, the supplement must clearly indicate the items
of the part which have not been changed.
Manufacturers who do not manufacture the ultraviolet lamps for their products need
not respond to Part 4 of the guide.
Many of the responses solicited by this guide can be made in the space provided.
Where attachments are required, so indicate in the space provided in the body of the
guide. Attachments should be numbered the same as the specific item of this guide to
which they are addressed. For example, an attachment responding to Item 2.2 should be
labeled Attachment 2.2.
Your reports and report supplements are to be submitted 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
If you have any questions, please contact the Ultraviolet Products Section, at
1-800-638-2041.

FDA 3801 (6/14)

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This page is deliberately blank.

PART 1
MANUFACTURER, REPORT TYPE, AND MODEL IDENTIFICATION
1.1

Manufacturer:
(Name)
(Address)

Corresponding Official (person preparing this report):
(Signature)

(Name)

(Title)
(Telephone Number)

(Email)

(Date of Report)

1.2

Designated Agent (for foreign manufacturers importing to the U.S., see 21 CFR
1005.25):
(Signature, or attach written agreement with agent)
(Name)
(Title)
(Telephone Number)

1.3

Importer(s) (list all importers if applicable):
(Name)
(Address)

1.4

Report Type:
(

) Initial

(

) Supplement to CDRH Accession No.

FDA 3801 (6/14)

(

) Model Change

3

submitted on

(Date)

1.5

Product Identification:
List the model designation (name and model number). If model is a member
of a model series or family, also provide a series or family designation.

(
(

) Booth
) Bed

1.6

Product Type:

1.7

Private Label Identification:

(
(

) Portable
) Tabletop

(

) Other

Supply the following information if the reported product is sold to other
manufacturers or suppliers for sale under a different name or as a component
of another product. (Provide a copy of each product label and user’s
instructions.)
Brand name

1.8

Name & address of company
under whose name product is sold

Model number

Intended Use:
Specify the intended function of the reported product (e.g., diagnostic or
therapeutic).

1.9

Other reporting requirements under FD&C Act:
Submission date
510(k)
PMA
Registration and Listing

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Report receipt
accession number

PART 2
MEDICAL ULTRAVIOLET PRODUCT DESCRIPTION
2.1

Attach a description of the ultraviolet product. The description must include:
a. exterior and interior structures of the assembled product;
b. description and specification for the reflector, timer, filters, ultraviolet lamps,
etc.;
c. photographs and diagrams which include parts identification;
d. electrical circuit diagram.
Information submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

2.2

Identify all ultraviolet lamps that are to be used in the product.
Ultraviolet lamp brand name

Model number

Number of lamps used in the product
Type of base or socket used for each ultraviolet lamp in the product (mogul
screwbase, medium bipin, etc.)
2.3

Timer:
a. Timer type
(
(

) Mechanical
) Electric

(
(

) Solid State/Digital
) Remote

b. Maximum timer interval (minutes)
Minimum timer interval (minutes)
c. What is the maximum timer interval error as a percent of that interval?
6
%
d. Can the product be operated if the timer is removed?
( ) Yes
( ) No (If “Yes,” explain why)

e. Can the product be operated if the timer fails or is defective?
( ) Yes
( ) No (If “Yes,” explain why)

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2.4

Protective eyewear:
a.

(Manufacturer’s Name)
(Address)
(Address)
(Model Designation)

b. Number of sets of protective eyewear supplied with the product
c. Provide the spectral transmittance in the following wavelength ranges:
%

(200-320 nm)

%

(320-400 nm)

%

(more than 400 nm)

d. Spectral transmittance measurements submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

e. If protective eyewear is not provided, please explain why:

2.5

Labeling:
a. Submit copies of the label which is used to determine the place of
manufacture. If this information is provided in code, please provide the key to
the code:

b. For each model of medical ultraviolet lamp and/or product, submit copies of all
warning signs, labels and instructions for installation, operation and use which
relate to electronic radiation safety, along with a photograph or drawing
showing the location of these labels.
Information submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

c. Attach any basis, including research or test data that you have, for any warning
labels provided.

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2.6

Irradiation:
a. Which parts of the living human body are to be irradiated by this product?

b. For the product to fulfill its function, which wavelength ranges are necessary?
1)

nm to

nm

2)

nm to

nm

3)

nm to

nm

c. What radiation emission levels (W/cm2), for each range, are necessary?
1)

nm

2)

nm

3)

nm

d. Attach justifications for your answers to Item 2.6b & c.
( ) None Available
( ) Attached
2.7

Product Efficacy:
a. If the product is to be used for a medical or dental function, provide
information on how well it achieves the purpose for which it is intended.

b. Are any contraindications for this product indicated?
( ) None
( ) Contraindications list attached
2.8

Minimum Use Distance:
a. What is the recommended minimum use distance for your product?

Explain why

b. Attach any basis, including research or test data that you have, for making or
not making this recommendation.
Documentation attached?
( ) Yes
( ) No (If “No,” explain why)

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c. Is the recommended minimum use distance listed on the product label?
( ) Yes
( ) No (If “No,” explain why)

2.9

Information to User:
a. Submit a copy of all instructions supplied to purchasers of the product
regarding:
1) Duration of single exposure.
( ) None
( ) Attached
2) Probable latency periods before appearance of any expected effects.
( ) None
( ) Attached
3) Non-beneficial aspects of excessive exposure to radiation from the
product.
( ) None
( ) Attached
4) Other information regarding the radiation safety of the product.
( ) None
( ) Attached
b. Which of the information in Item 2.9a is contained:
1) in labels on the product
2) on the container
3) in literature supplied

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PART 3
DESCRIPTION OF EMISSION CHARACTERISTICS
(This part should be completed only by manufacturers of products who manufacture the
fixtures but not the ultraviolet lamps used therein.)
3.1

Equipment:
a. Describe all spectroradiometric equipment used for the spectral measurement
of radiation emitted by your products. Include a description of its capability and
accuracy.
Description attached?
( ) Yes
( ) No (If “No,” explain why)

3.2

Spectral irradiance data to be provided under this part should be on a semi-log
graphical plot with the spectral irradiance [W/(cm2 nm)] on the logarithmic scale.
Preferably the measurements should be made at 1 meter or at the recommended
minimum use distance. Make these measurements both with and without any filter
that is used in the product, if the filter is removable or can be displaced by
breakage, etc.
a. Attach graphical plots of spectral irradiance as a function of wavelength over
the entire optical wavelength region in which the product emits radiation.
Plots Attached?
( ) Yes
( ) No

(If “No,” explain why)

b. What are the values of irradiance (W/cm2) integrated over the following
wavelength intervals?
(200-260 nm)
(260-290 nm)
(290-320 nm)
(320-400 nm)

3.3

Attach a brief description of the methods and procedures used for measurements
reported under Item 3.2.
Description attached?
( ) Yes
( ) No (If “No,” explain why)

NOTE: If the above testing is not performed in-house, please indicate who will be
performing the test and equipment being used.
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PART 4
LAMP EMISSION CHARACTERISTICS
(This part should be completed by manufacturers of products who also manufacture the
ultraviolet lamps used therein. It should also be completed by manufacturers of all other
ultraviolet radiation-emitting products, including ultraviolet lamps for which these reports
are required.)
4.1

Spectral characteristics (description of procedures for spectroradiometric
measurement):
a. At what distance from the product were the spectral irradiance measurements
meters
made?
b. What spectral irradiance standards were used?
1. Source of standard
2. When last calibrated
3. Uncertainty
c. At what wavelengths was the spectral irradiance of the product measured?

4.2

Attach a graphical plot of the spectral irradiance from the product in the 200 to
400 nm wavelength range. Plot should be on a semi-log graph with the spectral
irradiance on the logarithmic scale.
Graphical plot submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

4.3

Provide the irradiance values per nanometer [W/(cm2nm] over the wavelength range
of 200 to 400 nm. (See Appendix for Spectroradiometric Measurement and Testing
Procedures.)
Values submitted as an attachment?
( ) No (If “No,” explain why)
( ) Yes

4.4

Describe the equipment and procedures used for spectral irradiance measurements.
Include diagrams of light path, position, make, model and type of various optical
equipment and electronics used.
Description submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

4.5

Provide the uncertainties for the spectroradiometric measurements in the
wavelength range of 200 to 400 nm.
Material submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

4.6

Describe how you estimated the uncertainties within the specified wavelength range.
Description submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

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PART 5
QUALITY CONTROL TESTING
5.1

Preproduction and incoming parts test:
a. Describe all design and engineering tests conducted on the product.
Description submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

b. Describe all tests and/or checks made on incoming parts, including filters,
reflectors, timers and lamps, prior to their acceptance.
Description submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

5.2

Quality control tests or checks made during and after manufacture:
Describe the tests or checks conducted during or after manufacture that ensure
conformance with the specifications for the following:
a.
b.
c.
d.
e.

timer functioning and accuracy;
reflectors;
filters;
means to terminate exposure;
labeling.

Include a description of any sampling plan, instrumentation, test procedures and
rejection criteria used.
Description submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

5.3

Submit copies of all written quality control test procedures and checksheets used
for incoming component checks, manufacturing checks and final acceptance
checks.
Copies submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

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PART 6
LIFE AND RELIABILITY TEST
6.1

Attach information for all life and reliability tests on the product and its
components. If any life tests are done on an accelerated aging basis, so indicate
and provide details of the procedures and the formula or factors used in the
accelerated tests.
Description submitted as an attachment?
( ) Yes
( ) No (If “No,” explain why)

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APPENDIX
SPECTRORADIOMETRIC MEASUREMENTS AND TESTING PROCEDURES
There are several ways to determine radiometric values which, when correctly executed,
yield the same physical values. CDRH does not insist that any one method be used. We offer
the following suggestions only to help in establishing the important parameters. Physically
valid alternatives are, of course, acceptable.
Measurements, whose results are reported, should be performed using generallyaccepted radiometric principles and techniques. The information should be reported in
spectral irradiance values [W/(cm2 nm)]. All measurements should be made on the entire
device consisting of the light source and any related housing or attachments manufactured
or assembled for sale in the configuration in which they are intended to be used. However,
if the product has components such as a stand or some other component which does not
in any way alter the optical performance of the device, then these may be removed before
the device is measured. If the ultraviolet lamp must be mounted in some other housing
in order to facilitate the measurements, this should be done in such a manner that the
optical performance of the lamp is unchanged.
It is recommended that spectroradiometric measurements on the product be made as
follows:
The spectroradiometric measurements on the product should be made at the recommended minimum use distance from the product on an optic axis in the direction of the
maximum emission from the product. If more than one such direction exists, choose the one
that relates most closely to the intended uses and normal mounting configuration of the
product. The measurements on the continuum part of the spectrum should be made at
intervals of 1 nanometer (nm) in the ultraviolet wavelength region below 400 nm in which
the device emits. In addition, the spectral lines in the emission should be measured with
sufficiently narrow spectral bandpass so as to adequately measure the level of radiation
being emitted in those lines.
The measurements should be made with instruments calibrated against standards
of spectral irradiance. These standards should have been calibrated either by U.S. National
Bureau of Standards (NBS) or by another laboratory against standards calibrated by NBS
using NBS-recommended or generally-accepted techniques.
The standards should be used immediately before and after the measurements on the
product. Alternatively, if the standard is usually referred to after every reading while
scanning the wavelength scale, that method may be used. The result should be reported
in spectral irradiance values [W/(cm2 nm)].
CDRH generally recommends 100 percent testing of products in determination of compliance. For some tests and inspections, a sampling plan may be appropriate, i.e., use
of sampling procedure whereby release of noncomplying products is prevented by testing
less than 100 percent of the units produced. Results from acceptable statistical sampling
procedures may be used in answering many of the questions in Part 4. Examples of sampling plans are contained in MIL-Std-105D and MIL-Std-414.

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