Form Approved: OMB No. 0910-0025

Expiration Date: February 28, 2026

FORM FDA 3646 (05/23)

Mercury Vapor Lamp Products Radiation Safety Report

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 3646 (05/23)
REPORTING GUIDE 

FOR PRODUCT REPORTS ON 

HIGH INTENSITY MERCURY VAPOR DISCHARGE LAMPS

(21 CFR 1002)

Compiled by: 

Office of Compliance

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 3646 (05/23)
This page is deliberately blank.

FORM FDA 3646 (05/23)
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 3646 (05/23)
CONTENTS

Page

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

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

PART 1 - MANUFACTURER, PRODUCT, AND REPORT IDENTIFICATION . . . . . . . . . . . 1

PART 2 - DESCRIPTION OF THE REPORTED LAMP MODEL . . . . . . . . . . . . . . . . . . . . . 3

PART 3 - COMPLIANCE WITH THE GENERAL LABELING REQUIREMENTS . . . . . . . . . 5

PART 4 - COMPLIANCE WITH THE REQUIREMENTS FOR NON-SELFEXTINGUISHING LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

PART 5 - QUALITY CONTROL TESTS FOR NON-SELF-EXTINGUISHING 

LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

PART 6 - COMPLIANCE WITH THE REQUIREMENTS FOR SELF-EXTINGUISHING 

LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

PART 7 - QUALITY CONTROL, LIFE, AND RELIABILITY TESTS FOR SELFEXTINGUISHING LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

ii

FORM FDA 3646 (05/23)
INTRODUCTION

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 reporting guide has been prepared for use by 

manufacturers in the preparation of product reports concerning high intensity mercury 

vapor discharge lamps which are designed, intended, or promoted for illumination 

purposes, as required by paragraph 1002.10 and 1002.11 of Title 21 CFR (Code of 

Federal Regulations).

The material submitted in the report is expected to be concise and to-the-point. As 

required in 21 CFR 1002.7(b), the material submitted shall conform to the guide to the 

extent that it is possible or appropriate to do so.

Mercury Vapor Lamp Product Reports, Supplemental Reports, and Abbreviated 

Reports must be submitted to CDRH at the address below prior to the introduction 

of the reported products into commerce. (This includes products imported into 

the U.S.)

A complete Product Report is required for each mercury vapor lamp 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. CDRH suggests that a complete report on one model of a 

family be submitted, with a separate Supplemental Report for each of the other 

models in the family. The Supplemental Report should respond in detail to the parts 

of the guide where there are differences to report, referencing the number of the 

affected item. Items that are unchanged need only be referenced to the original 

report. 

A Product Report is required in Section 1002.10 to be submitted to the Director, 

Center for Devices and Radiological Health within 90 days following the effective 

date of listing the product under Section 1002.61 of the Regulations or prior to the 

introduction of the product into commerce, whichever is later. A new or modified 

model belonging to a previously reported model family must be reported in a 

Supplemental Report on that model family prior to its introduction into commerce. 

To avoid any unnecessary burden of reporting, the concept of model family is 

emphasized. You are requested to group your products into as small a number of 

model families as possible. A model family is a group of one or more mercury vapor 

lamp models having basically similar design with regard to the performance 

requirements in the standard, and which are manufactured using the same or very 

similar quality control and testing procedures. Mercury vapor lamp models within the 

same model family may have different wattage values, different shapes, and different 

sizes of sockets. The information reported for any model within a model family will be 

iii

FORM FDA 3646 (05/23)
largely the same as the information for every other model within the same family. 

Therefore, a complete report on one model of a model family shall be submitted with a 

separate supplemental report for each of the other models in that family. Supplemental 

reports should respond to the appropriate parts of the guide. The supplemental reports 

must clearly indicate all items of the part of the previous product reports that have not 

been changed, and must also report all changes in detail with reference to the affected 

items. 

The manufacturer must be sure that referenced information is accurate, current, and 

applicable to the reported models. Information that is applicable to more than one model 

family, but cannot be referenced in accordance with the above guidance, should be 

duplicated and included in each report.

An Abbreviated Report is acceptable for non-self-extinguishing, "R" type mercury vapor 

lamps. For such lamps, completion of Parts 1, 2, 3, 4, and 5 of this report will serve as 

the abbreviated report. 

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).

Your reports and correspondence are to be submitted to:

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 

DOCUMENT MAIL CENTER − WO66-G609 

ATTN: ELECTRONIC PRODUCT REPORTS 

10903 NEW HAMPSHIRE AVENUE 

SILVER SPRING, MD 20993-0002 

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.

iv

FORM FDA 3646 (05/23)
The Product Reporting Guides and Annual Reporting Guides are available from the 

Division of Small Manufacturers, International and Consumer Assistance in Rockville, 

Maryland at 1-800-638-2041. DSMICA should be contacted for requests of any current 

documents and the reporting guides mentioned here. 

If you have specific questions regarding regulations or filling out these reports, call 

DSMICA at 1-800-638-2041. 

v

FORM FDA 3646 (05/23)
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., mercury vapor lamps, sunlamps, laser 

products, TV. 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 

result in a decreased probability of detecting product noncompliance 

or increased radiation emission. 

c. 

Supplemental Reports should clearly reference the CDRH accession number of the 

Product Report and the appropriate sections of this guide.

Abbreviated Report (21 CFR 1002.12) - An Abbreviated Report is allowed for non-selfextinguishing or "R" type high intensity mercury vapor discharge lamps. Completing and 

submitting only Parts 1 through 5 of this report will fulfill the reporting requirements for 

the manufacturer of such products.

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 DSMICA by calling 

1-800-638-2041. 

vi

FORM FDA 3646 (05/23)
PART 1: MANUFACTURER, PRODUCT, AND REPORT IDENTIFICATION

1.1 Identification of Manufacturer

Prime contact/responsible person

Name of manufacturing firm 

Address

Telephone Email

Importer (if applicable)

Address

Telephone Email

Person preparing this report:

Signature

Name & Title

Telephone Email

1.2 Identification of Report 

1.2.1 Is this report submitted pursuant to paragraph (c) of 21 CFR 1002.61?

YES NO

1.2.2 Date of this report

1.2.3 Is this a complete Product Report ,

Supplemental Report , or Abbreviated Report ?

Mercury Vapor Lamp Report (9/95) Page 1

FORM FDA 3646 (05/23)
1.2.4 If this is a Supplemental Report, give CDRH accession number and date of the Product Report that 

it supplements.

Accession Number

Date

1.3 Identification of Product

1.3.1 Specify the type of lamp being reported.

non-self-extinguishing ,

self-extinguishing ,

mercury vapor ,

metal halide ,

other (specify)

1.3.2 Provide the model family designation.

1.3.3 Describe the model designation system within the family (ANSI designation system 

may be used).

1.3.4 Identify the model detailed in this report:

1.3.5 List all other models in the model family and specify if supplements are attached. 

(If not, explain why not.)

1.3.6 Supply the following information if the reported lamp is manufactured for and/or sold to other 

manufacturers or suppliers for sale under a different name. Provide a copy of each label and 

lamp packaging label. 

Brand name Model number 

Name & address of firm under 

whose name the lamp is sold

Mercury Vapor Lamp Report (9/95) Page 2

FORM FDA 3646 (05/23)
PART 2: DESCRIPTION OF THE REPORTED LAMP MODEL

2.1 Description of the product

2.1.1 Provide a description of the exterior, including information on the base or socket of the reported 

model. The descriptions may include the photographs or drawings with dimension reference 

scale.

photographs or drawings attached 

2.1.2 Provide a description of the interior structures of the reported model. The description may 

consist of photographs or drawings of the interior structures with parts and component 

identification and with scale dimensions.

photographs or drawings attached 

2.2 Description of the operation

2.2.1 Provide a brief general description of the theory and process of operation, including the start, 

the warm-up, and the steady-state condition of the reported model.

Mercury Vapor Lamp Report (9/95) Page 3

FORM FDA 3646 (05/23)
2.2.2 Provide information on lamp starting voltage, and operating current, of the reported model 

(reference may be made to ANSI standard).

2.2.3 Specify the type of ballast that meets the specifications of the reported model's ratings for 

starting and operation (reference may be made to ANSI standard).

2.2.4 Provide information on the life and warm-up time of the lamp.

2.2.5 If the reported model is a self-extinguishing lamp, provide descriptions in detail of the selfextinguishing mechanism, including its functioning theory and the conditions under which it 

renders the lamp inoperable.

Mercury Vapor Lamp Report (9/95) Page 4

FORM FDA 3646 (05/23)
PART 3: COMPLIANCE WITH THE GENERAL LABELING REQUIREMENTS

3.1 Does the reported lamp model have a label certifying that the lamp conforms to the provisions of 21 CFR 

1040.30 as required by 21 CFR 1010.2?

YES NO

3.1.1 Where is the certification label? On the lamp , or on the lamp 

packaging .

3.1.2 Submit a sample of the required certification label for the reported model, or a facsimile of 

the label if the label is inscribed on the lamp.

Sample attached

Facsimile attached

3.2 Does the reported lamp model have an identification label that conforms to the provisions 

of 21 CFR 1010.3?

YES NO

3.2.1 Where is the identification label? On the lamp , or 

on the lamp packaging .

3.2.2 Submit a sample of the required identification label for the reported model, or a 

facsimile of the label if the label is inscribed on the lamp.

Sample attached

Facsimile attached

3.2.3 How is the identification label permanently affixed, inscribed, or marked on the lamp 

and/or the lamp packaging? 

3.3 Is the reported lamp model permanently labeled or marked in such a manner that the name of the 

manufacturer and the month and year of manufacture of the lamp can be determined on the intact lamp and 

after the outer envelope is broken or removed? 

YES NO

Mercury Vapor Lamp Report (9/95) Page 5

FORM FDA 3646 (05/23)
3.3.1 Submit a facsimile of the above identification label or mark for the reported 

model.

Facsimile attached

3.3.2 If the name of the manufacturer and month and year of manufacture are expressed in code 

or symbols, you must provide the following information.

code key or explanation

The location of the coded information or symbols (please include picture, drawing, 

or diagram showing location). 

3.3.2 How are the name of the manufacturer and the date of the manufacture permanently 

labeled or marked on the lamp?

Mercury Vapor Lamp Report (9/95) Page 6

FORM FDA 3646 (05/23)
PART 4: COMPLIANCE WITH THE REQUIREMENTS FOR 

NON-SELF-EXTINGUISHING LAMPS

[This part should be completed when reporting non-self-extinguishing types of high intensity mercury vapor 

discharge lamps as defined in 21 CFR 1040.30(b) (1).]

4.1 Lamp labeling (submit explanations for all "NO" answers as attachments)

4.1.1 Is the reported lamp model clearly marked with the letter "R" on the outer 

envelope?

YES NO

4.1.2 Does the reported lamp model have the letter "R" also marked on another part of 

the lamp?

YES NO

If yes:

Identify the location of the letter "R" (include picture, drawing, or diagram 

showing location). 

(a)

(b) How is the letter "R" marked on the lamp?

(c) Is the letter "R" visible after the outer envelope of the lamp is broken or removed?

YES NO

4.2 Lamp packaging (submit explanations for all "NO" answers as attachments)

4.2.1 Does the lamp packaging for the reported lamp model clearly and prominently 

display the letter "R"?

YES NO

Mercury Vapor Lamp Report (9/95) Page 7

FORM FDA 3646 (05/23)
4.2.2 Does the lamp packaging for the reported lamp model clearly and prominently 

display the words: 

"WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave 

ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people 

will remain for more than a few minutes unless adequate shielding or other safety precautions are 

used. Lamps* that will automatically extinguish when the outer envelope is broken or punctured are 

commercially available"?

YES NO

*The words "certain types of" may be inserted before "lamps that will . . ."

4.2.3 The required warning statement for a non-self-extinguishing lamp appearson the lamp 

carton , outer wrapping , and/or

other means of containment (specify) for the 

reported model.

4.2.4 Submit a sample or facsimile of the label on lamp packaging as required by 1040.30(e) (2) 

for the reported model.

Sample attached

Facsimile attached

4.2.5 Describe other radiation safety-related information, if any, provided on or with the lamp 

packaging for the reported model and the reason for providing that information.

Mercury Vapor Lamp Report (9/95) Page 8

FORM FDA 3646 (05/23)
4.3 Lamp advertisement (submit explanations for all "NO" answers as attachments) 

4.3.1 Does the advertising for the reported model prominently display the words:

"WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave 

ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people 

will remain for more than a few minutes unless adequate shielding or other safety precautions are 

used. Lamps* that will automatically extinguish when the outer envelope is broken or punctured are 

commercially available"?

YES NO

*The words "certain types of" may be inserted before "lamps that will . . ."

4.3.2 The required warning statement in advertisement for a non-self-extinguishing lamp is 

included in the catalog , specification sheet , 

price list , and other description or commercial brochure and

literature for the reported model.

4.3.3 Submit copies of all advertisements containing the warning label as required by 

1040.30(e) (3) for the reported model. (Material may be submitted in draft form 

as long as it is marked as a draft, and final copies are to be submitted as report 

supplements when available.)

Copies of finals attached

Copies of drafts attached

4.3.4 Describe other radiation safety-related information, if any, provided in advertisement for 

the reported model and the reason for providing that information.

Mercury Vapor Lamp Report (9/95) Page 9

FORM FDA 3646 (05/23)
PART 5: QUALITY CONTROL TESTS FOR NON-SELF-EXTINGUISHING LAMPS

[This part should be completed by manufacturers of non-self-extinguishing types of high intensity mercury vapor 

discharge lamps as defined in 21 CFR 1040.30(b) (1).] 

5.1 Quality control tests

What tests or checks are conducted to assure the presence of the required labels and markings prior to 

and after completion of the manufacturing process?

Information attached

If not, explain

5.2 Action upon rejection

Describe actions to be taken for rejected units and rejected lots.

Information attached

If not, explain

Mercury Vapor Lamp Report (9/95) Page 10

FORM FDA 3646 (05/23)
PART 6: COMPLIANCE WITH THE REQUIREMENTS FOR SELF-EXTINGUISHING LAMPS

[This part should be completed when reporting self-extinguishing types of high intensity mercury vapor 

discharge lamps as defined in 21 CFR 1040.30(b) (1) and (7).]

6.1 Maximum cumulative operating time

6.1.1 The reported lamp model is designed to cease operation within a cumulative operating time not to 

exceed minutes, following complete breakage or removal of the outer 

envelope (with no fragment of the outer envelope extending more than 50 millimeters from 

the base shell).

6.1.2 The reported lamp model is designed to cease operation within a cumulative operating time not to 

exceed minutes, following breakage or removal of at least 3 square centimeters 

of continuous surface of the outer envelope.

Not applicable? 

6.2 Lamp labeling (submit explanations for all "NO" answers as attachments)

6.2.1 Is the reported lamp model clearly marked with the letter "T" on the outer envelope?

YES NO

6.2.2 Does the reported lamp model have the letter "T" on another part of the lamp?

YES NO

If yes:

(a) Identify the location of the letter "T" (include picture, drawing, or diagram showing 

location).

(b) How is the letter "T" marked on the lamp?

Mercury Vapor Lamp Report (9/95) Page 11

FORM FDA 3646 (05/23)
(c) Is the letter "T" visible after the outer envelope of the lamp is broken or removed?

YES NO

6.3 Lamp packaging (submit explanations for all "NO" answers as attachments)

6.3.1 Does the lamp packaging for the reported lamp model clearly and prominently display 

the letter "T"?

YES NO

6.3.2 Does the lamp packaging for the reported lamp model clearly and prominently display 

the words:

"This lamp should self-extinguish within 15 minutes after the outer envelope is broken or 

punctured. If such damage occurs, TURN OFF AND REMOVE LAMP to avoid possible 

injury from hazardous shortwave ultraviolet radiation"?

YES NO

6.3.3 The required warning statement for a self-extinguishing lamp appears on the lamp carton

, outer wrapping , and/or other means of containment (specify)

, for the reported model.

6.3.4 Submit a sample or a facsimile of the label on lamp packaging as required by 

21 CFR 1040.30(d) (3) for the reported model.

Sample attached

Facsimile attached

6.3.5 Describe other radiation safety-related information, if any, provided on or with the lamp 

packaging for the reported model and the reason for providing that information.

Mercury Vapor Lamp Report (9/95) Page 12

FORM FDA 3646 (05/23)
PART 7: QUALITY CONTROL, LIFE, AND RELIABILITY TESTS FOR 

SELF-EXTINGUISHING LAMPS

[This part should be completed by manufacturers of self-extinguishing types of high intensity mercury vapor 

discharge lamps as defined in 21 CFR 1040.30(b) (7). Wherever appropriate, information attached should include 

quality control procedures for the tests performed, parameters measured, physical conditions under which tests are 

conducted, measurement instrumentation and techniques, uncertainty evaluations of the measurements, sampling 

plans, the rejection criteria or confidence limits used, and the justification for the particular choice of such limits, 

methods of data analysis, etc.] 

7.1 Quality control tests conducted before the lamp is manufactured.

7.1.1 What tests were conducted on preproduction or prototype models prior to initiation of 

manufacturing to assure that the lamp was adequately designed for compliance within the 

performance standard? 

Information attached

If not, explain

7.1.2 What tests are conducted on the components of the self-extinguishing mechanism of the 

lamp prior to their incorporation into the lamp? 

Information attached

If not, explain

Mercury Vapor Lamp Report (9/95) Page 13

FORM FDA 3646 (05/23)
7.2 Quality control tests done during and after manufacture of the lamp.

7.2.1 What tests or checks are conducted on the components of the self-extinguishing mechanism 

of the lamp prior to their incorporation into the lamp?

Information attached

If not, explain

7.2.2 What tests or checks are conducted to assure proper functioning of the self-extinguishing 

mechanism after completion of the manufacturing process?

Information attached

If not, explain

7.2.3 What tests or checks are conducted to assure the presence of the required labels and markings 

prior to and after completion of the manufacturing process?

Information attached

If not, explain

Mercury Vapor Lamp Report (9/95) Page 14

FORM FDA 3646 (05/23)
7.3 Action upon rejection

Describe actions to be taken for rejected units and rejected lots if they have been rejected for problems 

concerning compliance with 21 CFR 1040.30. If retesting is required, state the criteria and procedures for 

retesting.

Information attached

If not, explain

7.4 Life and reliability tests

Provide descriptions of the life and reliability tests of the self-extinguishing mechanism of the reported model, 

including testing procedures, accept or reject criteria, lot and sample size, and action following rejection.

Information attached

If not, explain

7.5 Results of tests

7.5.1 Identify the type of tests related to compliance with 21 CFR 1040.30 for which results are 

presented, including reference to applicable portions of this part of the report as appropriate.

Mercury Vapor Lamp Report (9/95) Page 15

FORM FDA 3646 (05/23)
7.5.2 Identify the time period represented by results presented for each test. 

7.5.3 Provide information on the total number of units manufactured or received in the case of 

components, the number of units tested, and the number of units that initially failed to 

meet the quality control acceptance criteria for each test related to compliance with 

21 CFR 1040.30. 

Mercury Vapor Lamp Report (9/95) Page 16

FORM FDA 3646 (05/23)