FDA 3630 Guide for Preparing Product Reports on Sunlamps and Sunl

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

FORM FDA 3630 (10/14)
Guide for Preparing Product Reports on
Sunlamps and Sunlamp Products

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
PRAStaff@fda.hhs.gov
*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 3630 (10/14)

GUIDE FOR PREPARING
PRODUCT REPORTS
ON SUNLAMPS AND SUNLAMP PRODUCTS
(21 CFR 1002)

SEPTEMBER 1995

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

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FORM FDA 3630 (10/14)

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: dsmica@fda.hhs.gov
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 3630 (10/14)

PREFACE
Manufacturers of products subject to performance standards under the Federal
Food, Drug, and Cosmetic Act, Chapter V, Subchapter C - Electronic Product
Radiation Control are required to furnish various reports to the Center for
Devices and Radiological Health (CDRH). This guide is for use by
manufacturers of sunlamps, 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 a product report for products listed in Section
1002.61(a)(4). All product 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.

I. Paul Leggett, Chief
Nonmedical Radiological Devices Branch
Office of Compliance

ii
FORM FDA 3630 (10/14)

CONTENTS
Page
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

i

PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ii

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

v

DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

vii

.........................

1

PART 2: SUNLAMP PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

PART 3: ULTRAVIOLET LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

PART 4: EMISSION CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

PART 5: QUALITY CONTROL TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

PART 6: LIFE AND RELIABILITY TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12

......................

13

APPENDIX B. Spectroradiometric Measurement and Testing Procedures . . . . . . . . . . . . . . . . . . .

16

APPENDIX C. Policy on Maximum Timer Interval and Exposure Schedule
for Sunlamp Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

APPENDIX D. Policy on Lamp Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

PART 1: MANUFACTURER AND MODEL IDENTIFICATION

APPENDIX A. Sunlamp Standard as Amended on September 6, 1985

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FORM FDA 3630 (10/14)

INTRODUCTION

Sunlamp Product Reports, Supplemental Reports, and Abbreviated Reports must be submitted to the Center for
Devices and Radiological Health (CDRH) at the address below prior to introduction of the products into U.S.
commerce. (This includes products imported into the U.S.) In addition, all sunlamp product manufacturers are
required to register, list, and submit a 510(k) notification, as described in the Medical Device Requirements
section below.
Radiological Health Requirements
A complete Product Report is required for each product model or model family. Product Reports were
formerly called Initial or Model Change Reports. Since these reports contain essentially the same information,
the single term, Product Report, is now used. A model family is a group of two or more sunlamp products or
ultraviolet lamps with similar design, performance features, and intended function, and which are manufactured
using the same or very similar quality control testing procedures. A complete report on one model of a model
family should be submitted with a supplemental report for each other model in the family. The supplemental
report should respond to the appropriate parts of the report and indicate the differences in detail, referencing
the number of the items that are different as well as the ones that are the same as the original report.
When changes in a reported model's design or manufacturing procedures have been made that alter the emission
or radiation safety characteristics of the product(s), a supplemental report that describes the changes must be
submitted to CDRH. Supplemental reports are also required for new models belonging to a previously reported
model family. These reports should also respond to the appropriate parts of the reporting guide. If there is no
change from a prior report, this fact must be so stated. Report the changes in detail and reference the number
of the affected item. A new model family must be reported as a new product report. Responses in the new
report may reference earlier reports; however, cross-referencing of other reports should be minimized in order
to reduce reporting errors and to avoid confusion. The manufacturer must be sure that referenced information
is accurate, current, and applicable to the reported models.
Some of the information requested in this guide can be given in the space provided. Where attachments are
required, indicate as specified in the guide. If a question is not applicable to your product, write "N.A." next
to the question and indicate why it is not applicable. Attachments should be clearly numbered the same as the
specific part of the guide to which they are addressed. For example, an attachment responding to part 3.2
should be labeled "Attachment 3.2."
When new models of a lamp are introduced, if the models do not involve changes in radiation emission or
performance requirements, then the manufacturer need not report the models prior to introduction into
commerce. Rather, the manufacturer is only required to identify them in the annual report, or in quarterly
updates to the annual report. Quarterly updates to annual reports should be clearly marked as such and be
submitted prior to December 1, March 1, and/or June 1 when required. [See 21 CFR 1002.13(c).]
All symbols, units, and unusual terms in the report must be adequately defined and consistently used. Please
use the terms as defined in Section 1040.20(b) and in the IEEE Standard Dictionary of Electrical and
Electronic Terms (IEEE Std. 1001972 and ANSI C42.1001972).

v
FORM FDA 3630 (10/14)

All reports and correspondence must be addressed to:
Center for Devices and Radiological Health
Document Mail Center – W066-G609
Attn: Electronic Product Reports
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
When a report is received at CDRH, an accession number will be assigned to the report. The submitter will be
informed of the accession number in a letter acknowledging receipt of the report. The acknowledgement letter
is not a technical review of the report. The report will be reviewed by CDRH technical staff as soon as
possible and the submitter will be advised of the results. Report supplements should be clearly identified with
accession number of the original product report.
The Product Report and Annual Report forms are available online at:
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/RadiologicalHealthForms/default.htm
Manufacturers who do not manufacturer the ultraviolet lamps for their products need not respond to Part 3 of the
guide. Those who manufacture only the ultraviolet lamps need not respond to Part 2.
Medical Device Requirements
Please see this website for more information regarding establishment registration and device listing, http:www.
fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm.
Sections 510(b), (c), and (d) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the owner/operator
of an establishment to register with the FDA within 30 days after the beginning of manufacturer, initial distribution,
or processing of a device intended for human use. Please see this website for more information regarding
establishment registration and device listing,
http:www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm.
Sections 510(k) of the FFDCA requires those device manufacturers who must register to notify FDA, at least 90 days
in advance, of their intent to market a device. This is known as "Premarket Notification." There is no
printed form for 510(k) submissions; however, a format to be followed can be found in 21 CFR 807.87.
The date(s) of submission(s) and report receipt accession numbers for registration, listing, and 510(k)
submissions are to be supplied in Part 1 of this reporting guide.

vi
FORM FDA 3630 (10/14)

DEFINITIONS
NOTE: These definitions have been revised.
Product Report (21 CFR 1002.10) - A Product Report is a report submitted by a manufacturer of a regulated
product, e.g., sunlamps, late products, TVs. The Product Report describes the product, details how the
product complies with the standard, and explains the quality control program to assure compliance. A Product
Report can be used for families of products as well as for individual products.
Supplemental Report (21 CFR 1002.11) - A Supplemental Report provides information supplementary to a
previously submitted Product Report. It is used to report a new model in a previously reported model family, a
modification of a previously reported model, or other changes to a previous report (e.g., changes in testing
programs, additions or changes in user or service manuals, responses to CDRH report review letters).
Supplemental Reports are also required for changes that:
a.

affect actual or potential emission,

b.

decrease the degree of compliance with the performance standard, or

c.

result in a decreased probability of detecting product noncompliance or increased radiation
emission.

Supplemental Reports should clearly reference the CDRH accession number of the Product Report and the
appropriate sections of this guide.
Annual Report (21 CFR 1002.13) - An Annual Report summarizing the required records must be submitted by
September 1 for the 12 months ending on June 30 of the same year. In addition, the Annual Report is the
appropriate vehicle for identifying new models for which Supplemental Reports are not required. If the new
models do not involve changes in radiation emission or performance requirements, then the manufacturer need
only identify them in their annual report, or in quarterly updates to the annual report. Copies of the annual
report form to be followed are available from DSMA by calling 1-800-638-2041.
NOTE: Before preparing this report, the submitter should become familiar with the Federal Performance
Standard (which has been retyped as Appendix A) and the "Quality Control Guide for Sunlamp Products"
(HEW Publication FDA 84-8234). Reviewing and understanding these documents will make preparation of the
product report easier. However, because Appendix A has been excerpted from the Federal Register, it should
not be used for citing the regulation. Persons who wish to cite the regulation should consult the Federal
Register directly.

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FORM FDA 3630 (10/14)

PART 1: MANUFACTURER AND MODEL IDENTIFICATION
1.1

Manufacturer:
Manufacturer Firm
Address

Corresponding Official (person preparing this report):
Signature
Name & title
Telephone number
Email address
Firm's prime contact or responsible person if different from above:
Name & title
Telephone number
Email address
1.2

Designated Agent (for manufacturers exporting to the U.S., see 21 CFR 1005.25):
Signature
Name & title

(or attach written agreement with agent)

Address

Telephone number
Email address
1.3

Importer(s) (List all importers and addresses if applicable):

1.4

Date of this Report:

Sunlamp Product Report (9/95)
FORM FDA 3630 (10/14)

Page 1

1.5

Report Type: (
(

) Sunlamp Product Report, or
)

Supplement to CDRH Accession No.

submitted on (date)
1.6

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

1.7

Product Type:
(

1.8

) Sunlamp Product

(

) Ultraviolet Lamp

(

) Booth

(

) HID

(

) Bed

(

) Reflector Spot

(

) Portable

(

) Other:

(

) Tabletop

(

) Other:

Private Label Identification:
Supply the following information if the reported product is sold to other manufacturers or suppliers for
sale under a different name or as component of another product. (YOU MUST PROVIDE A COPY
OF EACH PRODUCT LABEL AND USER'S INSTRUCTIONS.)
Name & address of company
Brand name
Model number
under whose name product is sold

1.9

Other reporting requirements under the FFDCA (as described in the Introduction):
Submission Date

Report Receipt Accession Number

510(k)
Reg. & Listing

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Page 2

PART 2: SUNLAMP PRODUCT DESCRIPTION

2.1

Attach a description of the sunlamp product. The description MUST include:
a.

exterior and interior structures of the assembled product;

b.

description and manufacturer's specification for the reflector, timer, filters, ultraviolet lamps,
ballasts, etc.;

c.

photographs and diagrams which include parts identification;

d.

electrical circuit diagram.

Information submitted as an attachment?
(

2.2

(

) Yes

) No (If "No," explain why)

Identify all ultraviolet lamps that are to be used in the sunlamp product.
Lamp manufacturer

Full model number

Brand name

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

2.3

Timer [21 CFR 1040.20(c)(2)]:
a.

Timer type
(

) Mechanical

(

) Solid State/Digital

(

) Token

(

) Electric

(

) Credit card

(

) Remote

Sunlamp Product Report (9/95)
FORM FDA 3630 (10/14)

Page 3

b.

Maximum timer interval (minutes)
Minimum timer interval (minutes)

c.

Can the timer be reset before the end of the preset time interval?
(

) Yes

(

) No

d.

What is the maximum timer interval error as a percent of that interval? ±

e.

What is the maximum recommended exposure time indicated on the label required by 21 CFR
1040.20(d)(1)(iv)?

f.

If the timer is operated using a token or credit card, what mechanism assures that: (1) the
maximum recommended exposure time is not exceeded, and (2) the recommended multiple
exposure time intervals are included?

g.

When radiation emission from a sunlamp product has been terminated for any reason, including
termination by a timer, is resumption of such emission possible without manual activation by
the user?
(

h.

) Yes

(

%

) No (If "No," explain why)

Describe the control on the sunlamp product that enables the user to manually terminate
radiation emission at any time without disconnecting the electrical plug or removing the lamp
[21 CFR 1040.20(c)(3)].

Its location on the product:

Sunlamp Product Report (9/95)
FORM FDA 3630 (10/14)

Page 4

2.4

Protective eyewear [21 CFR 1040.20(c)(4)]:
a.

Manufacturer's name
Address
Model designation

b.

Number of sets of protective eyewear supplied with the sunlamp product

c.

Provide the spectral transmittance in the following wavelength ranges:

d.

200-320 nm

%

320-400 nm

%

more than 400 nm

%

Spectral transmittance measurements submitted as an attachment?
(

e.

(

) No (If "No," explain why)

Can the user see clearly enough while wearing the protective eyewear to reset the timer?
(

2.5

) Yes

) Yes

(

) No (If "No," explain why)

Labeling:
Submit copies or accurate reproduction of the following labels along with a photograph or drawing
showing the location (on the product) of the required labels.
a.

Certification label (21 CFR 1010.2)

b.
c.

Identification label (21 CFR 1010.3)
Warning label [21 CFR 1040.20(d)(1)]

d.

Provide the data and calculations used to determine the maximum recommended exposure time
and exposure schedule in accordance with the "Policy on Maximum Timer Interval and
Exposure Schedule for Sunlamp Products," dated August 21, 1986. See Appendix C.
Labeling and other material submitted as an attachment?
(

) Yes

Sunlamp Product Report (9/95)
FORM FDA 3630 (10/14)

(

) No (If "No," explain why)

Page 5

2.6

Ultraviolet lamp labels:
Are the ultraviolet lamps incorporated in your product labeled as required by 21 CFR 1040.20(d)(2)?
(

) Yes

(

) No (If "No," explain why)

Submit copies or accurate reproduction of the following labels along with a photograph or drawing
showing the location (on the product) of the required labels.
a.
b.
c.

Certification label (21 CFR 1010.2)
Identification label (21 CFR 1010.3)
Warning label [21 CFR 1040.20(d)(2)]

Labels submitted as an attachment?
(

2.7

) Yes

(

) No (If "No," explain why)

User instructions [21 CFR 1040.20(e)(1)]:
Submit copies of all instructions that you provide to the users.
User instructions submitted as an attachment?
(

) Yes

Sunlamp Product Report (9/95)
FORM FDA 3630 (10/14)

(

) No (If "No," explain why)

Page 6

PART 3: ULTRAVIOLET LAMPS

3.1

Describe the ultraviolet lamp, including design specifications and a picture or diagram.
Description submitted as an attachment?
(

) Yes

(

) No (If "No," explain why)

3.2

Type of base on lamp:

3.3

List sunlamp product(s) that is (are) designed to be used with the lamp.
Manufacturer and brand name

3.4

Model number

Replacement lamps:
a.

Identify the brand name and model designation of all lamps for which this lamp is promoted as a
replacement. [This must also be in the lamp user instructions per 21 CFR 1040.20(e)(2)(iii).]
Manufacturer & brand name

b.

Model number

Private label model number(s)

Provide the data and calculations used to determine lamp compatibility (equivalency). See Appendix
D, "Policy on Lamp Compatibility," dated September 2, 1986.
Material submitted as an attachment?
( ) No (If "No," explain why)
( ) Yes

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Page 7

c.

Provide specifications which document equivalency (identical lamp) between manufacturer's brand
and private label(s).
Material submitted as an attachment?
( ) No (If "No," explain why)
( ) Yes

3.5

Labeling:
Submit a copy or facsimile of the following labels required by the performance standard.
Certification label (21 CFR 1010.2)
Identification label (21 CFR 1010.3)
Warning label [21 CFR 1040.20(d)(2)]
Labels submitted as an attachment?
(

3.6

) Yes

(

) No (If "No," explain why)

Identify the location of each required label on the product and packaging.
Location on product

Location on packaging

Certification label
Identification label
Warning label
3.7

User instructions [21 CFR 1040.20(e)(2)]:
Submit a copy of the user instructions that you provide to the users.
User instructions submitted as an attachment?
( ) Yes
( ) No (If "No," explain why)

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Page 8

PART 4: EMISSION CHARACTERISTICS
4.1

Spectral characteristics:
Description of procedures for spectroradiometric measurement.
a.

At what distance from the product were the spectral irradiance measurements made?
meters

b.

What spectral irradiance standards were used?

c.

4.2

1.

Source (accreditation body) of standard(s)

2.

When last calibrated

3.

Uncertainty

At what wavelengths was the spectral irradiance of the product measured?

Attach a graphical plot of the spectral irradiance from the product in the 200-710 nm wavelength range.
Plot should be on a semilog graph with the spectral irradiance on the logarithmic scale.
Graphical plot submitted as an attachment?
( ) No (If "No," explain why)
( ) Yes

4.3

Provide the irradiance values per nanometer (Watt/cm2/nm) over the wavelength range of 200 to 400 nm.
See Appendix B for Spectroradiometric Measurement and Testing Procedures.
See Appendix C for Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.
This document provides the formula and weighting factors to determine the exposure schedule and
maximum recommended exposure time.
Table submitted as an attachment?
( ) No (If "No," explain why)
( ) Yes

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Page 9

4.4

Irradiance ratio [21 CFR 1040.20(c)(1)]:
Watts/cm2 (200-260 nm) ÷ Watts/cm2 (260-320 nm)
Watts/cm2 (260-320 nm) ÷ Watts/cm2 (320-400 nm)

4.5

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?
( ) No (If "No," explain why)
( ) Yes

4.6

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

4.7

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

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Page 10

PART 5: QUALITY CONTROL TESTING

5.1

Production and incoming parts test:
a.

Describe all design and engineering tests conducted on the product.
Description submitted as an attachment

b.

Describe all tests and/or checks made on incoming parts, including filters, reflectors, timers,
ballasts, and lamps, prior to their acceptance to ensure that the final product complies with the
performance standard for sunlamp products (21 CFR 1040.20).
Description submitted as an attachment

5.2

Quality control tests or checks made during and after manufacture:
Describe the tests or checks conducted during and after manufacture that ensure compliance with the
standard for the following:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.

timer functioning and accuracy (at multiple intervals, including maximum);
irradiance ratio;
protective eyewear transmittance;
means to terminate exposure;
warning label;
identification label;
certification label;
user instructions - adequacy and presence;
presence and quantity of protective eyewear;
other:

Include detailed descriptions of all sampling plans, instrumentation (including calibration), test
procedures (including in-process and finished product quality control inspections), and rejection criteria
used.
Description submitted as an attachment
5.3

Submit copies of all written quality control test procedures and check sheets (demonstrating actual test
results) used for incoming component tests, manufacturing tests, and final acceptance tests.
Copies submitted as an attachment

NOTE: Section 21 CFR 1010.2(c) requires that certification be based on tests in accordance with the standard
or on a testing program in accordance with good manufacturing practices (21 CFR 820). Failure to maintain an
adequate testing program will result in disapproval of the program by CDRH.

Sunlamp Product Report (9/95)
FORM FDA 3630 (10/14)

Page 11

PART 6: LIFE AND RELIABILITY TESTING

6.1

Attach information for all life and reliability tests on the product and its components, as required by 21
CFR 1002.30(a)(3). 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. Provide this
information (including results, data and/or condition of component at each inspection or test interval) for
the following tests:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.

timer;
irradiance ratio;
protective eyewear
means to terminate emission control;
warning label;
certification label;
identification label;
mechanical durability;
electrical durability;
filter;
reflectors;
other:

Description submitted as an attachment?
(

) Yes

Sunlamp Product Report (9/95)
FORM FDA 3630 (10/14)

(

) No (If "No," explain why)

Page 12

APPENDIX A - Federal Regulations - Sunlamp Product Performance Standard
21 CFR § 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp
products
(a) Applicability.
(1) The provisions of this section, as amended are applicable as specified herein to the following products manufactured on or
after September 8, 1986.
(i) Any sunlamp product.
(ii) Any ultraviolet lamp intended for use in any sunlamp product.
(2) Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before September 8, 1986, are subject to the
provisions of this section as published in the Federal Register of November 9, 1979 (44 FR 65357).
(b) Definitions. As used in this section the following definitions apply:
(1)
"Exposure position" means any position, distance, orientation, or location relative to the radiating surfaces of the
sunlamp product at which the user is intended to be exposed to ultraviolet radiation from the product, as recommended
by the manufacturer.
(2)
"Intended" means the same as "intended uses" in §801.4.
(3)
"Irradiance" means the radiant power incident on a surface at a specified location and orientation relative to the radiating
surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square
centimeter (W/cm2).
(4)
"Maximum exposure time" means the greatest continuous exposure time interval recommended by the manufacturer of
the product.
(5)
"Maximum timer interval" means the greatest time interval setting on the timer of a product.
(6)
"Protective eyewear" means any device designed to be worn by users of a product to reduce exposure of the eyes to
radiation emitted by the product.
(7)
"Spectral irradiance" means the irradiance resulting from radiation within a wavelength range divided by the wavelength
range as the range becomes vanishingly small, expressed in units of watts per square centimeter per nanometer
(W/(cm2/nm)).
(8)
"Spectral transmittance" means the spectral irradiance transmitted through protective eyewear divided by the spectral
irradiance incident on the protective eyewear.
(9)
"Sunlamp product" means any electronic product designed to incorporate one or more ultraviolet lamps and intended for
irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 200 and 400
nanometers, to induce skin tanning.
(10)
"Timer" means any device incorporated into a product that terminates radiation emission after a preset time interval.
(11)
"Ultraviolet lamp" means any lamp that produces ultraviolet radiation in the wavelength interval of 200 to 400
nanometers in air and that is intended for use in any sunlamp product.
(c) Performance requirements.
(1) Irradiance ratio limits. For each sunlamp product and ultraviolet lamp, the ratio of the irradiance within the wavelength range
of greater than 200 nanometers through 260 nanometers to the irradiance within the wavelength range of greater than 260
nanometers through 320 nanometers may not exceed 0.003 at any distance and direction from the product or lamp.
(2) Timer system.
(i) Each sunlamp product shall incorporate a timer system with multiple timer settings adequate for the recommended
exposure time intervals for different exposure positions and expected results of the products as specified in the label
required by paragraph (d) of this section.
(ii) The maximum timer interval(s) may not exceed the manufacturer's recommended maximum exposure time(s) that is
indicated on the label required by paragraph (d)(1)(iv) of this section.
(iii) No timer interval may have an error greater than 10 percent of the maximum timer interval of the product.
(iv) The timer may not automatically reset and cause radiation emission to resume for a period greater than the unused
portion of the timer cycle, when emission from the sunlamp product has been terminated.
(v) The timer requirements do not preclude a product from allowing a user to reset the timer before the end of the preset
time interval.
(3) Control for termination of radiation emission. Each sunlamp product shall incorporate a control on the product to enable the
person being exposed to terminate manually radiation emission from the product at any time without disconnecting the electrical
plug or removing the ultraviolet lamp.
(4) Protective eyewear.
(i) Each sunlamp product shall be accompanied by the number of sets of protective eyewear that is equal to the maximum
number of persons that the instructions provided under paragraph (e)(1)(ii) of this section recommend to be exposed
simultaneously to radiation from such product.
(ii) The spectral transmittance to the eye of the protective eyewear required by paragraph (c)(4)(i) of this section shall not
exceed a value of 0.001 over the wavelength range of greater than 200 nanometers 320 nanometers and an value of 0.01
over the wavelength range of greater than 320 nanometers through 400 nanometers, and shall be sufficient over the
wavelength greater than 400 nanometers to enable the user to see clearly enough to reset the timer.

Page 13
FORM FDA 3630 (10/14)

(5) Compatibility of lamps. An ultraviolet lamp may not be capable of insertion and operation in either the "single-contact
medium screw" or the "double-contact medium screw" lampholders described in American National Standard C81.10-1976,
Specifications for Electric Lamp Bases and Holders--Screw Shell Types, which is incorporated by reference. Copies are available
from the American National Standards Institute, 1430 Broadway, New York, NY 10018, or available for inspection at the Office
of the Federal Register, 1100 L St. NW, Washington, DC 20408.
(d) Label requirements. In addition to the labeling requirements in Part 801 and the certification and identification requirements of §§
1010.2 and 1010.3, each sunlamp product and ultraviolet lamp shall be subject to the labeling requirements prescribed in this paragraph
and paragraph (e) of this section.
(1) Labels for sunlamp products. Each sunlamp product shall have a label(s) which contains:
(i) A warning statement with the words "DANGER--Ultraviolet radiation. Follow instructions. Avoid overexposure.
As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may
cause premature aging of skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT
IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your
sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a
history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are
unlikely to tan from the use of this product."
(ii) Recommended exposure position(s). Any exposure position may be expressed either in terms of a distance specified
both in meters and in feet (or in inches) or through the use of markings or other means to indicate clearly the
recommended exposure position.
(iii) Directions for achieving the recommended exposure position(s) and a warning that the use of other positions may
result in overexposure.
(iv) A recommended exposure schedule including duration and spacing of sequential exposures and maximum exposure
time(s) in minutes.
(v) A statement of the time it may take before the expected results appear.
(vi) Designation of the ultraviolet lamp type to be used in the product.
(2) Labels for ultraviolet lamps. Each ultraviolet lamp shall a label which contains:
(i) The words "Sunlamp--DANGER--Ultraviolet radiation. Follow instructions."
(ii) The model identification.
(iii) The words "Use ONLY in fixture equipped with a timer."
(3) Label specifications.
(i) Any label prescribed in this paragraph for sunlamp products shall be permanently affixed or inscribed on an exterior
surface of the product when fully assembled for use so as to be legible and readily accessible to view by the person being
exposed immediately before the use of the product.
(ii) Any label prescribed in this paragraph for ultraviolet lamps shall be permanently affixed or inscribed on the product
so as to be legible and readily accessible to view.
(iii) If the size, configuration, design, or function of the sunlamp product or ultraviolet lamp would preclude compliance
with the requirements for any required label or would render the required wording of such label inappropriate or
ineffective, or would render the required label unnecessary, the Director, Office of Communication, Education, and
Radiation Programs, 10903 New Hampshire Avenue, Building 66, Room 4312, Silver Spring, MD 20993-0002, Center
for Devices and Radiological Health, on the Center's own initiative or upon written application by the manufacturer, may
approve alternate means of providing such label(s), alternate wording for such label(s), or deletion, as applicable.
(iv) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by §§1010.2(b) and
1010.3(a), the manufacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the
lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture
are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily
accessible to view. The name of the manufacturer and month and year of manufacture affixed or inscribed on the
exterior surface of the lamp may be expressed in code or symbols, if the manufacturer has previously supplied the Director,
Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health, with the key
to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp. The label or tag
affixed or inscribed on the lamp packaging may provide either the month and year of manufacture without abbreviation,
or information to allow the date to be readily decoded.
(v) A label may contain statements or illustrations in addition to those required by this paragraph if the additional
statements are not false or misleading in any particular; e.g., if they do not diminish the impact of the required
statements; and are not prohibited by this chapter. (Information collection requirements approved by the Office of
Management and Budget under control number 0910-0195.)
(c) Instructions to be provided to users. Each manufacturer of a sunlamp product and ultraviolet lamp shall provide or cause to be
provided to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, adequate instructions
for use to avoid or to minimize potential injury to the user, including the following technical and safety information as applicable:
(1) Sunlamp products. The user's instructions for a sunlamp product shall contain:
(i) A reproduction of the label(s) required in paragraph (d)(1) of this section prominently displayed at the beginning of
the instructions.
(ii) A statement of the maximum number of people who may be exposed to the product at the same time and a warning
that only that number of protective eyewear has been provided.

Page 14
FORM FDA 3630 (10/14)

(iii) Instructions for the proper operation of the product including the function, use, and setting of the timer and other
controls, and the use of protective eyewear.
(iv) Instructions for determining the correct exposure time and schedule for persons according to skin type.
(v) Instructions for obtaining repairs and recommended replacement components and accessories which are compatible
with the product, including compatible protective eyewear, ultraviolet lamps, timers, reflectors, and filters, and which
will, if installed or used as instructed, result in continued compliance with the standard.
(2) Ultraviolet lamps. The users' instructions for an ultraviolet lamp not accompanying a sunlamp product shall contain:
(i) A reproduction of the label(s) required in paragraph (d)(1)(i) and (2) of this section, prominently displayed at the
beginning of the instructions.
(ii) A warning that the instructions accompanying the sunlamp product should always be followed to avoid or to minimize
potential injury.
(iii) A clear identification by brand and model designation of all lamp models for which replacement lamps are promoted,
if applicable.
(Information collection requirements approved by the Office of Management and Budget under control number 0910-0195.)
(f) Test for determination of compliance. Tests on which certification pursuant to §1010.2 is based shall account for all errors and
statistical uncertainties in the process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with
age of the product. Measurements for certification purposes shall be made under those operational conditions, lamp voltage, current, and
position as recommended by the manufacturer. For these measurements, the measuring instrument shall be positioned a the
recommended exposure position and so oriented as to result in the maximum detection of the radiation by the instrument.
Dated: August 12, 1985
Joseph P. Hile, Associate Commissioner for Regulatory Affairs.

Page 15
FORM FDA 3630 (10/14)

APPENDIX B
SPECTRORADIOMETRIC MEASUREMENT 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 generally-accepted radiometric principles
and techniques. The information should be reported in spectral irradiance values (Watts/(cm-2/nm-1)). For
sunlamp products, 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 sunlamp or sunlamp product should be made at the
recommended exposure position 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 a 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 Institutes of Standards and Technology [NIST,
previously known as the National Bureau of Standards (NBS)] or by another laboratory against standards
calibrated by NIST using NIST-recommended or generally-accepted techniques.
The standards should be used immediately before and after the measurements on the product. Alternatively, if
you usually refer to the standard after every reading while scanning the wavelength scale you may use that
method. The results should be reported in spectral irradiance values (Watts/(cm-2/nm-1)).
CDRH generally recommends 100 percent testing of products for determination of compliance. For some tests
and inspections, a sampling plan may be appropriate, i.e., use of a 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.

Page 16
FORM FDA 3630 (10/14)

APPENDIX C - Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products,
dated August 21, 1986
POLICY:
The Center for Devices and Radiological Health (CDRH) will use the following criteria to evaluate the
adequacy of the exposure schedule and the recommended maximum exposure time (and therefore the
maximum timer interval):
1) The maximum recommended exposure time (and maximum timer interval) must not exceed
a value which will result in an exposure of four (4) times the minimal erythema dose (MED)
for untanned Type II skin (always burns, then tans slightly). This is based on the CDRH
Erythema Action Spectrum [proposed action spectrum of Commission Internationale de
L'Eclairage (CIE), modified by CDRH]. See Appendix A for the action spectrum and
weighting factors and equations needed to derive it.
The formula for determining the recommended maximum exposure time, "Te" in seconds is:
Te = 624 J/m2
Σ ViRi

where Standard MED = 156 J/m2 at 296 nm
Vi = weighting factor
Ri = irradiance in W/m2

2) The recommended maximum exposure time must not exceed a value which will result in an
exposure of four (4) times the minimal melanogenic dose (MMD) for untanned Type II skin.
This is based on the melanogenic action spectrum developed by Parrish et al. (1982). See
Appendix B for this action spectrum.
The formula for determining the recommended maximum exposure time, "Tm" in seconds, is:
Tm = 1836 J/m2
Σ JiRi

where Standard MMD = 459 J/m2 at 296 nm
Ji = weighting factor
Ri = irradiance in W/m2

3) The recommended exposure schedule should provide for exposures of no more than 0.75 MED
three times the first week, gradually increasing the exposure the following weeks until maximum
tanning has occurred (approximately four weeks total) and then provide for maintenance of a tan
by biweekly or weekly exposures of up to four (4) MEDs or four (4) MMDs, whichever is less.
CDRH believes that the above criteria balance the need to limit acute (and delayed) damages from
unintentionally long exposure and the need to provide for single exposure durations adequate to
achieve and maintain a tan.
Walter E. Gundaker, Director
Office of Compliance
Center for Devices and
Radiological Health

Page 17
FORM FDA 3630 (10/14)

The equations describing the curve are:

Vi (λ) = 1.0 (250 < λ < 302 nm)
Vi (λ) = 100.114 (302 ¯ λ) (302 < λ < 325 nm)
Vi (λ) = 100.0161 (159 ¯ λ) (325 < λ < 405 nm)

The MMD as function of wavelength has been interpolated (using log MMD) from the action spectrum
for melanogenesis of Type II skin (Parrish et al. 1982).

Page 18
FORM FDA 3630 (10/14)

Parrish Melanogenesis Type II Skin (1982) Normalized to 292 nm
Wavelength
(nm)

Ji

Wavelength
(nm)

Ji

Wavelength
(nm)

Ji

250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301

.378409
.374828
.371248
.367714
.364225
.360783
.35734
.353943
.350547
.347196
.343891
.340632
.337419
.334206
.331039
.327672
.327413
.326954
.326449
.32599
.325531
.325072
.324613
.324154
.323695
.323236
.321445
.319609
.317865
.316075
.314285
.312541
.31075
.351694
.398008
.450427
.509732
.576885
.652851
.738778
.836088
.861518
.8874598
.91435
.94212
.970625
1.
.990959
.982054
.973287
.96429
.886993

302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353

.815892
.750391
.690261
.502296
.36551
.265997
.193565
.14087
.102497
.74589E-01
.054301
.395016E-01
.341137E-01
.294593E-01
.254384E-01
.219683E-01
.189709E-01
.163821E-01
.141467E-01
.122143E-01
.105481E-01
.911137E-02
.786745E-02
.679336E-02
.586616E-02
.506748E-02
.437483E-02
.377812E-02
.326265E-02
.281741E-02
.243276E-02
.210089E-02
.181447E-02
.176123E-02
.170982E-02
.165978E-02
.161113E-02
.156385E-02
.151841E-02
.147388E-02
.143074E-02
.138897E-02
.134812E-02
.130864E-02
.127054E-02
.123336E-02
.11971E-02
.116222E-02
.112825E-02
.10952E-02
.106307E-02
.103232E-02

354
355
356
357
358
359
360
361
362
363
364
365
366
367
368
369
370
371
372
373
374
375
376
377
378
379
380
381
382
383
384
385
386
387
388
389
390
391
392
393
394
395
396
397
398
399
400
401
402
403
404
405

.100202E-02
.972644E-03
.944186E-03
.916645E-03
.890022E-03
.863859E-03
.838613E-03
.813826E-03
.789958E-03
.767007E.03
.747729E-03
.722942E-03
.666943E-03
.615075E-03
.567338E-03
.523272E-03
.48288E-03
.44547E-03
.410953E-03
.379097E-03
.34972E-03
.322593E-03
.297577E-03
.274534E-03
.253236E-03
.233591E-03
.215506E-03
.213532E-03
.211558E-03
.209963E-03
.207702E-03
.205821E-03
.203939E-03
.202057E-03
.200221E-03
.189296E-03
.196594E-03
.194804E-03
.193014E-03
.191224E-03
.18948E-03
.187735E-03
.186037E-03
.184339E-03
.18264E-03
.180988E-03
.179336E-03
.177683E-03
.176077E-03
.17447E-03
.172864E-03
.171257E-03

Page 19
FORM FDA 3630 (10/14)

APPENDIX D - POLICY ON LAMP COMPATIBILITY, dated September 2, 1986
A replacement lamp will be considered compatible with (or equivalent to) another (original) lamp if:
1)

The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail
to comply with the standard or to become defective as defined by 21 CFR 1003.2, and;

2)

the lamp is as effective, within plus or minus ten percent, as the original lamp, in causing
erythema and melanogenesis.

It should be noted that the above criteria apply to sunlamp product exposure schedule and maximum timer
interval which must appear on the product's labeling. The manufacturer should use the following
procedure to establish conformance with criterion number 2 above:
1)

Calculate the recommended maximum exposure time for a single original lamp (Y) using the CDRH
August 21, 1986, guidance ("Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp
Products").

2)

Calculate the recommended maximum exposure time for a single replacement lamp (X) using the
same method.

3)

Compare the values; if the value for the replacement lamp (X) is within plus or minus 10% of the
value of the original lamp (Y), the lamp would be considered compatible (Y = X ± 10%).

The distance(s) used for this comparison should represent the typical use distance range in products using
the original (Y) lamp.
The CDRH welcomes comments on this policy.

Walter E. Gundaker, Director
Office of Compliance
Center for Devices and
Radiological Health

Page 20
FORM FDA 3630 (10/14)