Form Approved: OMB No. 0910-0025 

Expiration Date: February 28, 2026

FORM FDA 3630 (02/23)

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.
FORM FDA 3630 (02/23)

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 (02/23)

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
FORM FDA 3630 (02/23)

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FORM FDA 3630 (02/23)

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 (02/23)

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 (02/23)

CONTENTS

Page

FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

PART 1: MANUFACTURER AND MODEL IDENTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . 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

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

iii
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FORM FDA 3630 (02/23)

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 (02/23)

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/DeviceRegulation 

andGuidance/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 (02/23)

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.

vii
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FORM FDA 3630 (02/23)

Page 1 

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 (or attach written agreement with agent)

Name & title

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 (02/23)

Page 2 

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:

Sunlamp Product ( )

( ) Booth

( ) Bed

( ) Portable

( ) Tabletop

Other: ( )

( ) Ultraviolet Lamp

( ) HID

Reflector Spot ( )

Other: ( )

1.8 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.)

Brand name Model number

Name & address of company

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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FORM FDA 3630 (02/23)

Page 3 

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?

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

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

Lamp manufacturer Brand name Full model number

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 ( )

( ) Token

( ) Credit card

Solid State/Digital ( )

( ) Electric

( ) Remote

Sunlamp Product Report (9/95)
FORM FDA 3630 (02/23)

Page 4 

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?

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

h. 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 (02/23)

Page 5 

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:

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

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

2.5 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. Identification label (21 CFR 1010.3)

c. 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 ( ) No (If "No," explain why)

Sunlamp Product Report (9/95)
FORM FDA 3630 (02/23)

Page 6 

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. Certification label (21 CFR 1010.2)

b. Identification label (21 CFR 1010.3)

c. Warning label [21 CFR 1040.20(d)(2)]

Labels submitted as an attachment?

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

2.7 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 ( ) No ( ) (If "No," explain why)

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FORM FDA 3630 (02/23)

Page 7 

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 Model number

3.4 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 Model number Private label model number(s)

b. 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?

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

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Page 8 

c. Provide specifications which document equivalency (identical lamp) between manufacturer's brand 

and private label(s).

Material submitted as an attachment?

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

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?

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

3.6 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)

Sunlamp Product Report (9/95)
FORM FDA 3630 (02/23)

Page 9 

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?

1. Source (accreditation body) of standard(s)

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 200-710 nm wavelength range. 

Plot should be on a semilog graph with the spectral irradiance on the logarithmic scale.

Graphical plot submitted as an attachment?

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

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?

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

Sunlamp Product Report (9/95)
FORM FDA 3630 (02/23)

Page 10 

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?

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

4.6 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)

4.7 Describe how you estimated the uncertainties within the specified wavelength range.

Description submitted as an attachment?

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

Sunlamp Product Report (9/95)
FORM FDA 3630 (02/23)

Page 11 

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. timer functioning and accuracy (at multiple intervals, including maximum);

b. irradiance ratio;

c. protective eyewear transmittance;

d. means to terminate exposure;

e. warning label;

f. identification label;

g. certification label;

h. user instructions - adequacy and presence;

i. presence and quantity of protective eyewear;

j. 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 (02/23)

Page 12 

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. timer;

b. irradiance ratio;

c. protective eyewear

d. means to terminate emission control;

e. warning label;

f. certification label;

g. identification label;

h. mechanical durability;

i. electrical durability;

j. filter;

k. reflectors;

l. other:

Description submitted as an attachment?

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

Sunlamp Product Report (9/95)
FORM FDA 3630 (02/23)

Page 13 

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.
FORM FDA 3630 (02/23)

Page 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.)

(e) 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.
FORM FDA 3630 (02/23)

Page 15 

(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.
FORM FDA 3630 (02/23)

Page 16 

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.
FORM FDA 3630 (02/23)

Page 17 

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

ΣViRi

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

ΣJiRi

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
FORM FDA 3630 (02/23)

Page 18 

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).
FORM FDA 3630 (02/23)

Page 19 

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

Wavelength (nm) Ji

250 .378409

251 .374828

252 .371248

253 .367714

254 .364225

255 .360783

256 .35734

257 .353943

258 .350547

259 .347196

260 .343891

261 .340632

262 .337419

263 .334206

264 .331039

265 .327672

266 .327413

267 .326954

268 .326449

269 .32599

270 .325531

271 .325072

272 .324613

273 .324154

274 .323695

275 .323236

276 .321445

277 .319609

278 .317865

279 .316075

280 .314285

281 .312541

282 .31075

283 .351694

284 .398008

285 .450427

286 .509732

287 .576885

288 .652851

289 .738778

290 .836088

291 .861518

292 .8874598

293 .91435

294 .94212

295 .970625

296 1.

297 .990959

298 .982054

299 .973287

300 .96429

301 .886993

Wavelength (nm) Ji

302 .815892

303 .750391

304 .690261

305 .502296

306 .36551

307 .265997

308 .193565

309 .14087

310 .102497

311 .74589E-01

312 .054301

313 .395016E-01

314 .341137E-01

315 .294593E-01

316 .254384E-01

317 .219683E-01

318 .189709E-01

319 .163821E-01

320 .141467E-01

321 .122143E-01

322 .105481E-01

323 .911137E-02

324 .786745E-02

325 .679336E-02

326 .586616E-02

327 .506748E-02

328 .437483E-02

329 .377812E-02

330 .326265E-02

331 .281741E-02

332 .243276E-02

333 .210089E-02

334 .181447E-02

335 .176123E-02

336 .170982E-02

337 .165978E-02

338 .161113E-02

339 .156385E-02

340 .151841E-02

341 .147388E-02

342 .143074E-02

343 .138897E-02

344 .134812E-02

345 .130864E-02

346 .127054E-02

347 .123336E-02

348 .11971E-02

349 .116222E-02

350 .112825E-02

351 .10952E-02

352 .106307E-02

353 .103232E-02

Wavelength (nm) Ji

354 .100202E-02

355 .972644E-03

356 .944186E-03

357 .916645E-03

358 .890022E-03

359 .863859E-03

360 .838613E-03

361 .813826E-03

362 .789958E-03

363 .767007E.03

364 .747729E-03

365 .722942E-03

366 .666943E-03

367 .615075E-03

368 .567338E-03

369 .523272E-03

370 .48288E-03

371 .44547E-03

372 .410953E-03

373 .379097E-03

374 .34972E-03

375 .322593E-03

376 .297577E-03

377 .274534E-03

378 .253236E-03

379 .233591E-03

380 .215506E-03

381 .213532E-03

382 .211558E-03

383 .209963E-03

384 .207702E-03

385 .205821E-03

386 .203939E-03

387 .202057E-03

388 .200221E-03

389 .189296E-03

390 .196594E-03

391 .194804E-03

392 .193014E-03

393 .191224E-03

394 .18948E-03

395 .187735E-03

396 .186037E-03

397 .184339E-03

398 .18264E-03

399 .180988E-03

400 .179336E-03

401 .177683E-03

402 .176077E-03

403 .17447E-03

404 .172864E-03

405 .171257E-03
FORM FDA 3630 (02/23)

Page 20 

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