3646 Mercury Vapor Lamp Product Report

Submission Report
Section: Main Menu
Welcome

Welcome to the CDRH Electronic
Submissions Software (CeSub)
This software application is intended to automate the current paper submission process.
This software contains a number of data capturing tools and helpful dialog boxes to
reduce redundant responses for you, and to allow us to capture data in a more useful,
structured format. These benefits will enable CDRH to improve our review process and
reduce lengthy review times.
For your convenience, an email account has been established to support any questions
that you may have regarding the use of this software. Please email any questions or
comments to the CeSub team at: [email protected]. Please be sure to include your
name, company name and contact information in the email.
Thank you again for using our electronic product reporting software. We look forward to
hearing from you soon.
What type of product is this submission referring to?

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Radiation Emitting Product (OMB No. 0910-0025; Expiration Date: December 31, 2006)

Welcome (Cont.)

Department of Health and Human Services
Food and Drug Administration

Form Approved:
OMB Number 0910-0025
Expiration Date: December 31, 2006
Section: eRadHealth Menu
Role
What is your role?

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Manufacturer

Submission Information
What Type of Submission is this? (Supplements should be submitted selecting the same document type as the original
report.)

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Radiation Safety Report (Product Report)
What Type of Product is this Annual Report about?

What Type of Correspondence is this?

What Type of Product is this Radiation Safety Report about?
High Intensity Mercury Vapor Discharge and Metal Halide Lamps
What Type of Product is this Variance Request about?

What Laser Light Show Documents are you filing?

Section: Manufacturer Data
Introduction

Electronic Product Radiation Safety
Reporting Form
This software application is intended to automate the hard copy product reporting forms
in the effort of the Center for Devices and Radiological Health (CDRH) to become
capable of accepting electronic submissions from industry and to improve our review
process. This CDRH Electronic Submission (CeSub) software is the next version of the
application the CDRH is developing to allow us to accept all Radiological Health reports
and other submissions electronically and improve the ability of CDRH to accomplish its
mandated product and industry evaluations in a timely and efficient manner.
We have already received many electronic submissions and are looking forward to
receiving more in the future. With this new release of the software we have updated our
procedures for packaging a submission to make this a smoother process for all. All
electronic reports (your new CD-ROMs) and any other documents you are submitting in
hard copy because they cannot be provided in an acceptable electronic format must be
mailed to CDRH. A signed hard copy of the submittal letter generated by the submission
software, should be printed out and included with your electronic submission. This
printed documentation will provide the Document Control Room with enough
information to log the submission. The electronic submissions should be sent directly to
the Document Control room, which is the same process for the standard paper

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submission.
The submission must be addressed to:
Electronic Product Document Control (HFZ-309), Attn: CeSub Team, Center for
Devices and Radiological Health, 2094 Gaither Road, Rockville, MD 20850
After sending your submission to the Document Control Room, please send an email to
the [email protected] email account so we will know that your submission is
forthcoming. Please remember that all correspondence concerning your submission
MUST be sent to the Electronic Product Document Control (HFZ-309), at the above
letterhead address. Correspondence sent to any address other than the one above will not
be considered as part of your official notification submission. Please refer to this
guidance for information on current fax and e-mail practices at
www.fda.gov/cdrh/ode/a02-01.html. You should also be familiar with the regulatory
requirements for radiological products at www.fda.gov/cdrh/comp/eprc.html and medical
devices available at Device Advice www.fda.gov/cdrh/devadvice/.
If you have specific questions regarding the software, please contact the CeSub team by
email at: [email protected].
Thank you for using our electronic product reporting software. Please communicate your
comments and criticisms to the CeSub team as often as you like.
Thank you for your continued support of the CDRH eSubmission Pilot Program.
General Information

General Information for Radiological
Health Products
Manufacturers of products subject to performance standards under the Federal Food,
Drug, and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product
Radiation Control are required to furnish various reports to the Center for Devices and
Radiological Health (CDRH).
The Radiological Health staff, CDRH developed this software application for the Product
and Annual reports. This application will assist manufacturers of electronic products that
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 requirements 1,2,3.
Reports submitted on radiation safety of electronic products must follow the appropriate

form (21 CFR 1002.7). This software application serves the same report responsibility, so
long as the submitter or manufacturer prints out the cover letter and sends it in along with
the CD containing the report files. The submitter of the report will receive an
acknowledgment letter (or email message) with the accession number that CDRH assigns
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.
CDRH DOES 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 product and
Annual Reports and to comply with all applicable importation requirements (21CFR
1005). If there are deficiencies, CDRH 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. CDRH 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 (21CFR 1003 - 1004) for products already introduced into commerce.
CDRH can now accept and process 'CeSub' electronic submissions at this time, if all
attachments are PDF files only, and the cover letter is printed out and included with a real
signature. Translate any text that appears in a language other than English into English in
a complete and accurate manner. Keep a copy (save a copy to your hard drive) of the
completed report in your records.
We are providing our new software applications for the old reporting forms upon request
during this beta testing period of development in Spring, 2005. Other regulatory
information is still available on the Internet under
http://www.fda.gov/cdrh/comp/eprc.html. No copyright exists for these forms.
Reproduce these forms as needed. If you would like to comment on the reporting forms,
website, or future electronic submissions, you may direct the comments to the address
below.
A complete Product Report is required for each product model or model family. Product
Reports are now more generally referred to as Radiation Safety Reports to distinguish the
Radiological Health submissions from medical device submissions. 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 form where there are differences to report, referencing
the number of the affected item. Items that are unchanged will still appear in the
supplement from the original report.

When new models of a product are introduced, if the models satisfy the criteria for an
established reporting exemption or if the new 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 may be submitted using the Annual Report software included in this
application. [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 1040.10(b) and in the IEEE
Standard Dictionary of Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI
C42.1001972).
Definitions

Definitions for Rad Health Products
Manufacturers
Manufacturer is any person or organization engaged in the business of manufacturing,
assembling, or importing of electronic products (21 CFR1000.3(n)). Manufacturers of
electronic products subject to 21CFR1000-1050 must:
•
•
•
•
•

•
•
•

Design and manufacture their products to be in compliance with applicable
performance standards;
Test their products to assure compliance;
Certify compliance of their products;
Maintain test and distribution records and a file of correspondence concerning
radiation safety, safety complaints, and inquiries;
Use the published reporting forms or electronic software application to submit
reports to CDRH, including Product reports describing the manner of compliance
of the product design and testing program and Annual Reports summarizing their
compliance testing;
Report accidental radiation occurrences (i.e., possible, suspected,or known
exposures);
Report any radiation defects or noncompliances; and
Recall (i.e., repair, replace, or refund the purchase price of) defective or
noncompliant products.

Accidental Radiation Occurrences
An accidental radiation occurrence means a single event or series of events that has/have
resulted in injurious or potentially injurious exposure of any person to electronic product

radiation as a result of the manufacturing, testing, or use of an electronic product.

Importers
Importer is any person of organization engaged in the business of importing electronic
products. An importer is considered to be a manufacturer. The requirements for
Manufacturers given above also apply to importers if the requirements have not been
done by the foreign manufacturer.

United States Agent for Foreign Manufacturers
Every manufacturer of electronic products, prior to offering such product for importation
into the United States, shall designate a permanent resident of the United States as the
manufacturer`s agent upon whom service of all processes, notices, orders, decisions, and
requirements may be made for and on behalf of the manufacturer as provided in section
536(d) of the Radiation Control for Health and Safety Act of 1968 (21U.S.C. 360mm(d))
and this section. The agent maybe an individual, a firm, or a domestic corporation. For
purposes of this section, any number of manufacturers may designate the same agent.

From The Federal Food, Drug, and Cosmetic Act
Sec 536 [21 U.S.C. 360mm](d) Designation of agent for purposes of service
It shall be the duty of every manufacturer offering an electronic product for importation
into the United States to designate in writing an agent upon whom service of all
administrative and judicial processes, notices, orders, decisions, and requirements may be
made for and on behalf of said manufacturer, and to file such designation with the
Secretary, which designation may from time to time be changed by like writing, similarly
filed. Service of all administrative and judicial processes, notices, orders, decisions, and
requirements may be made upon said manufacturer by service upon such designated
agent at his office or usual place of residence with like effect as if made personally upon
said manufacturer, and in default of such designation of such agent, service of process,
notice, order, requirement, or decision in any proceeding before the Secretary or in any
judicial proceeding for enforcement of this part or any standards prescribed pursuant to
this part may be made by posting such process, notice, order, requirement, or decision in
the Office of the Secretary or in a place designated by him by regulation.
Sec. 531 [21 U.S.C. 360hh] (1) the term ''electronic product radiation''means:
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic
product as the result of the operation of an electronic circuit in such product.

Sec. 531 [21 U.S.C. 360hh](2) the term ''electronic product''means:
(A) any manufactured or assembled product which, when in operation,(i) contains or
acts as part of an electronic circuit and (ii) emits (or in the absence of effective
shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component,
part, or accessory of a product described in clause (A) and which when in operation
emits (or in the absence of effective shielding or other controls would emit) such
radiation.
Burden to Industry

Paperwork Reduction Act Statement
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, 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:
Food and Drug Administration CDRH (HFZ-240)
1350 Piccard Drive Rockville, MD 20850

Please DO NOT RETURN this application to this 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."
Manufacturer Responsible for Product Compliance
Note:

This is the firm that takes responsibility for certification that the product meets the performance standard. This
firm develops and maintains the quality control and testing program that is the basis for the certification of this
product. Additionally, this firm usually is the owner of the product design and manufacturing process design.

Copy from the establishment address book
Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number

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Fax Number
Mailing Location:
Address

Responsible Individual
Note:

The responsible individual is the highest level and most responsible individual affiliated with this
establishment.

Copy from contact address book

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Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Manufacturer's Reporting Official
Note:

This is the person at the manufacturing facility that is knowledgeable and responsible for addressing all
aspects of the testing and quality control procedures for certification as reported to FDA in the product report.
Documentation of changes intesting and quality control procedures submitted to FDA must be signed by this
individual.

Copy from contact address book
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

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Electronic Signature
Electronic signature (not available in this release of the software)

File Attachment

Report Submitter
Note:

The submittermaybe a consulting individual or firm providing assistance in report preparation and
maintenance. All documents prepared by the submitter must have the manufacturer's reporting official
signature for authenticity of submitted documentation.

Copy from contact address list

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Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Parent Establishment
Is there a parent establishment?
Copy from contact address book
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:

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Address

Manufacturer Designated United States Agent
Note:

Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.

Is there a United States agent that has been designated by the manufacturer?

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Section: Product Data
Product Type Reported
What product type is being reported? *Please note that this list of 66 product types are grouped according to their radiation
type and applicable regulations (e.g., laser products, microwave products, ionizing products, etc.)

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What is the product code?

*

If you know the three letter code, enter it in the space provided.
If you do not,
- Click the filter search icon (next to the trash can). You will see a product code filter dialog box.
-Enter a keyword to search the database. You will be provided a list of product codes from which to choose.
(If you are not finding the correct product, try other words and/or variations of the keywords.)
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code.
- If you do not find the code that you are looking for, use RZZ (Other)
Product Code
Device Class
Classification Panel
C.F.R. Section
If Other, please identify the specific product type.

Report Information
Is this the first time you've submitted a report on the particular type of product selected in the
Product Type Reported section?

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Since this is not the first time you've reported on this type of product, then is this a report supplement to
a previously reported model family?
Provide the Accession Number of the report for which this is a supplement (Do not enter any Device
Premarket Application or Notification document number here, such as PMAs, 510(k)s, IDEs, etc.):
Are you requesting a new variance, a renewal, extension or amendment to a previous variance?

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If you are requesting a renewal, extension, or amendment, please provide the variance number that
was issued by CDRH.
Error:

If you are requesting a new variance, renewal, extension, or amendment, you must file a Variance Request
separate from this report. To do this, open a new report (File > New) and select either "Laser Light Show
Variance Request" or "Variance Request, Other" as your Type of Submission in the Submission Information
Screen. If you select "Variance Request, Other" you must select the product for which you are requesting a
variance at the end of the screen.

Noncompliances or Defects
Does this document or any of its attachments contain:
A self-declaration or notification of noncompliance or defect?

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Provide an explanation:

Responses to Noncompliances or Defects
Does this documentor any of its attachments contain:
A refutation of noncompliances?

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A request for an exemption from notification and corrective action?

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Information on corrective actions you may be conducting?

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A description of any design changes for future production?

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Provide an explanation:

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (1010.5)?

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Exemption for products for government use from reporting and recordkeeping (1002.51)?

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Special exemption of products from reporting and/or recordkeeping (1002.50)?

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Request for approval of alternate labeling?

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Application for alternate test procedures (1010.13)?

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Provide an explanation:

Attach any necessary files.

File Attachment

Variance Requests
Message:

Click the "Add" button to select the desired requirement from which you are seeking a variance.

This submission includes an application for a variance from certain requirements.
Item
Provide an explanation and attach supporting files, if necessary. Click on the Add... button below to attach files.
Details
File Attachment

Error:

In addition to the electronic copy of this submission, please be sure to submit one hard-copy of the signed
variance request document to the following address:
Division of Dockets Management (HFA-305)
Food and Drug Administration
Rm 1061, 5630 Fishers Lane
Rockville, MD 20852

Responses to Communications from FDA
Does this document or any of its attachments contain:
A response to an inspection?

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What was the date of the inspection?
A response to a warning letter from the Food and Drug Administration (FDA)?

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What was the date of the Warning Letter?
A response to a report review inquiry from the Center for Devices and Radiological Health (CDRH) (the
inquiry may have been in the form of a letter, email, or phone call)?

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What was the date of the inquiry?
A response to any other communication from FDA?
What was the date of the communication?
Provide an explanation:

Use Environment
Who are the intended users?
[
[
[
[
[
[
[
[
[

] Children and/or Youth
] Consumers
] Elderly
] Employees/Workers
] Engineers or Scientists
] General Public
] Medical Staff
] Patients
] Other

What is the use environment?
[
[
[
[
[
[
[
[
[
[

] Consumer Home
] Hospital or Clinic
] Industrial Facility or Factory
] Office/Warehouse/Store
] Outdoors
] Public Arena
] Schools, Gymnasium/Auditorium
] Lab or Research Facility
] Transportation Facility
] Other

Please select the best match for the affected population:
[
[
[
[
[
[
[

] Children and/or Youth
] Consumers
] Elderly
] Employees/Workers
] Engineers or Scientists
] General Public
] Medical Staff

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[ ] Patients
[ ] Other

Additional Information
Is there any other relevant information or additional comments that would help expedite the review of this submission? Click the
Add... button below to attach any supporting files.
File Attachment
Details

Private Labeling
Is the product sold by other companies under different brand names?

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Medical Devices
Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one of these numbers has
been assigned by FDA yet.

If it has not been assigned yet, provide an explanation and submit it as soon as you receive such a filing number.

Electromagnetic Compatibility and Interference

Electromagnetic Compatibility with other Products
Provide description of analysis and indicate any shielding you have for your product to protect other products from EMI:

Susceptibility to EMI from other Products
Provide description of analysis and indicate any protective shielding your product has to protect it from EMI:

Section: Mercury Vapor Lamp Products
Lamp Type
Specify the type of lamp being reported.
If "Other" has been selected, please specify further.

Product Description

*

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. Click on the Add... button below to add and
select the files to be attached.

*

File Attachment
Details
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. Click on the Add...
button below to add and select the files to be attached.

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File Attachment
Details

Description of Operation
Provide a brief general description of the theory and process of operation including the start, warmup, and the steady-state
condition of the reported model.

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File Attachment
Details
Provide information on lamp starting voltage, and operating current of the reported model (reference may be made to ANSI
standard).

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File Attachment
Details
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).

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File Attachment
Details
Provide information on the life and warm-up time of the lamp.

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File Attachment
Details
If the reported model is a self-extinguishing lamp, provide descriptions in detail of the self- extinguishing mechanism including its
functioning theory and the conditions under which it renders the lamp inoperable.
File Attachment
Details

General Labeling Requirements
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?

*

Where is the certification label?
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.
File Attachment
Details
If no, provide an explanation.

Does the reported lamp model have an identification label that conforms to the provisions of 21 CFR 1010.3?

*

Where is the identification label?
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.
File Attachment
Details
How is the identification label permanently affixed, inscribed or marked on the lamp and/or the lamp packaging?

If no, provide an explanation.

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?

*

Attach a facsimile of the above identification label or mark for the reported model.
File Attachment
Details
How are the name of the manufacturer and the date of the manufacture permanently labeled or marked on the lamp?

If the name of the manufacturer and month and year of manufacture are expressed in code or symbols, you must provide the
translation or explanation.
Item
Provide the location of the coded information or symbols (please attach a picture, drawing, or diagram showing location).
File Attachment
Details

Requirements for Non-Self-Extinguishing Lamps
Note:

This part should be completed when reporting non-self-extinguishing types of high intensity mercury vapor
discharge lamp as defined in 21 CFR 1040.30 (b) (1).

Lamp Labeling
Is the reported lamp model clearly marked with the letter R on the outer envelope?
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details
Does the reported lamp model have the letter R also marked on another part of the lamp?
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details
Identify the location of the letter R. Attach a picture, drawing, or diagram showing the location.

File Attachment
Details
How is the letter R marked on the lamp?

Is the letter R visible after the outer envelope of the lamp is broken or removed?
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details

Lamp Packaging
Does the lamp packaging for the reported lamp model clearly and prominently display the letter R?
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details
Does the lamp packaging for the reported lamp model clearly and prominently display the following warning? WARNING:
This lamp can cause serious skin burn and eye inflamation 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. Certain types of lamps that will automatically extinguish when the outer envelope is
broken or punctured are commercially available.
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details
The required warning statement for a non-self-extinguishing lamp appears on the
following location(s) for the reported model(s):

[ ] Lamp Carton
[ ] Outer Wrapping
[ ] Other Means of Containment

If Other Means of Containment was selected, please specify further.

Attach a sample or facsimile of the label on lamp packaging as required by 1040.30 (e) (2) for the reported model.
File Attachment
Details
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.

Lamp Advertisement
Does the advertising for the reported model prominently display the following warning statement? WARNING: This lamp
can cause serious skin burn and eye inflamation 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. Certain types of lamps that will automatically extinguish when the outer envelope is broken or
punctured are commercially available.
Provide an explanation as a file attachment or text in the box below.
File Attachment

Details
The required warning statement in advertisement for a non-self-extinguishing lamp is included in:

[ ] The Catalog
[ ] Specification Sheet
[ ] Price List
[ ] Other Description or
Commercial Brochure and
Literature

If Other Description or Commercial Brochure and Literature was selected, please specify further.

Attach 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.) Click on the Add button below to add and select files to be attached.
File Attachment
Details
Describe other radiation safety-related information, if any, provided in advertisement for the reported model and the reason for
providing that information.

Quality Control Tests for Non-Self-Extinguishing Lamps
Note:

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).

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? Click on the Add button below to add and select files to be attached.
File Attachment
Details
Action Upon Rejection
Describe actions to be taken for rejected units and rejected lots. Click on the Add button below to add and select files to be
attached.
File Attachment
Details

Requirements for Self-Extinguishing Lamps
Note:

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).

Maximum Cumulative Operating Time
The reporting 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.) Provide the number of minutes.
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 three square centimeters of continguous surface of the outer
envelope. the outer envelope (with no fragment of the outer envelope extending more than 50 millimeters from the
base shell.) Provide the number of minutes or indicate NA if not applicable.

Lamp Labeling
Is the reported lamp model clearly marked with the letter T on the outer envelope?

Provide an explanation as a file attachment or text in the box below.
File Attachment
Details
Does the reported lamp model have the letter T on another part of the lamp?
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details
Identify the location of the letter T. Attach a picture, drawing, or diagram showing the location.
File Attachment
Details
How is the letter T marked on the lamp?

Is the letter T visible after the outer envelope of the lamp is broken or removed?
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details

Lamp Packaging
Does the lamp packaging for the reported lamp model clearly and prominently display the letter T?
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details
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?"
Provide an explanation as a file attachment or text in the box below.
File Attachment
Details
The required warning statement for a self-extinguishing lamp appears on the
following location(s) for the reported model(s):

[ ] Lamp Carton
[ ] Outer Wrapping
[ ] Other Means of Containment

If Other Means of Containment was selected, please specify further.

Attach a sample or facsimile of the label on lamp packaging as required by 1040.30 (d) (3) for the reported model.
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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.

Quality Control, Life, and Reliability Tests (Self-Extinguishing Lamps)
Note:

This part should be completed by manufacturers of self-extinguishing type of high intensity mercury vapor
discharge lamp 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.

Quality Control Tests
Quality control tests conducted before the lamp is manufactured:
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? Click on the Add... button below to add and select the
necessary files to be attached.
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What tests are conducted on the components of the self-extinguishing mechanism of the lamp prior to their incorporation into the
lamp? Click on the Add... button below to add and select the necessary files to be attached.
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Quality control tests done during and after manufacture of the lamp:
What tests or checks are conducted on the components of the self-extinguishing mechanism of the lamp prior to their
incorporation into the lamp? Click on the Add... button below to add and select the necessary files to be attached.
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What tests or checks are conducted to assure proper functioning of the self-extinguishing mechanism after completion of the
manufacturing process? Click on the Add... button below to add and select the necessary files to be attached.
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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? Click on the Add... button below to add and select the necessary files to be attached.
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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. Click on the Add... button below to
add and select the necessary files to be attached.
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Life and Reliability Tests
Provide descriptions of the life and reliability tests of the self-extinguishing mechanism of reported model, including testing
procedures, accept or reject criteria, lot and sample size and action following rejection. Click on the Add... button below to add and
select the necessary files to be attached.

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Results of Tests
Identify the type of tests related to compliance with 21CFR 1040.30 for which results are presented including reference to
applicable portions of this part of the report as appropriate. Click on the Add... button below to add and select the necessary files
to be attached.
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Identify the time period represented by results presented for each test. Click on the Add... button below to add and select the
necessary files to be attached.
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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. Click on the Add... button below to add and select the necessary files to be attached.
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FDA 3646 (03/06) Mercury Vapor Lamp Products Radiation Safety Report