3636 Laser Light Show Annual 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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Annual Report
What Type of Product is this Annual Report about?
Laser Light Shows
What Type of Correspondence is this?

What Type of Product is this Radiation Safety Report about?

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:
•
•
•
•
•

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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 26 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.)

Report Information
Is this submission a supplement to an Annual Report submitted previously for the same reporting
year?

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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
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)?
What was the date of the inquiry?

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A response to any other communication from FDA?

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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
] 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?

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: General Annual Report
Part 1 Report Identification
Message:

This Annual Report is submitted in accordance with 21 CFR 1002.11 for the period:

-

From July 1, 20 _ _(Provide the last two digits of the year)

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-

Through June 30, 20 _ _(Provide the last two digits of the year)

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If your products meet other voluntary industry standards, provide below:
Item

Standard Title and Reference Number

Category

Organization

If your product is designed to meet additional voluntary industry standards, list them in the table below.
Item

Part 2 Production Status
Production Status (Click on the right button and select the statement that applies to your firm and take the indicated action)

Part 3 Current Production Tabulation
Item: 1

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Model Family Designation:
Model Designation (Name and/or Number):

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Accession Number (For previously reported models, CDRH will have assigned this
number and reported it to you)

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Note:

Each product that CDRH regulates is assigned a product code by CDRH.
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)

Identify the product code.
Product Code
Device Class
Classification Panel
C.F.R. Section
Number of Units Produced

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Introduction Into Commerce (MM/DD/YYYY)

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Is this model now discontinued but was produced during this reporting period?

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If so, provide the date of discontinuation:
Plant Location
Establishment Information:
Establishment Name
Division Name
FDA Establishment Identifier (FEI)
Central File Number (CFN)
Registration Number
Owner/Operator Number
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Provide any information that is needed for any of the items as an attachment.
File Attachment

Part 4 Procedures for Quality Control and Testing

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Note:

You are required by 21 CFR 1002.30 (a) (1) and (2) to maintain written procedures for quality control and
testing. The procedures in use and those submitted in the Product Reports should be reviewed and updated.
Compare your current procedures with those submitted in your Product Reports.

The written procedures for assessing and controlling radiation safety have been reviewed. (These include prototype
testing, incoming materials testing, assembly testing, retesting after repair, and service testing.) The procedures for
maintaining quality control testing equipment have also been reviewed. All procedures are up-to-date, complete,
and accurate.

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The initial report(s) provided to CDRH for each model family currently in production have been reviewed and the
procedures contained within are up-to-date, complete, and accurate.

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4.1 Current Procedures
Item: 1

Provide the current procedures as a PDF file attachment here, identifying the model accession number or provide an explanation.
File Attachment
Details
Model Accession Number:

Part 5 Summary of Test Results
Item: 1

Note:

You are required by 21 CFR 1002.30 (a) (2) to maintain results of quality control tests. For each product
introduced into commerce, you should evaluate test results to be certain that the total program is adequate to
assure radiation safety and compliance with the standard (21 CFR 1040.10 and 1040.11).

Model or Show Designation:

*

Number of units tested for compliance with performance requirements:

*

Number of units tested for compliance labels:

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Select additional tests performed on this model:

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If you selected "Other," provide an explanation:

Select the Type of Measure for the test:
If you selected "Other," provide an explanation:

Specify the Measurement Mean or Range:
Specify the Standard Deviation Measurement:
Indicate the type of components that could affect radiation safety of the product if they fail:

Specify the number of component failures:

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Part 6 Correspondence Concerning Radiation Safety
Note:

You are required by 21 CFR 1002.30 (a) (4) to maintain copies of communications to or from dealers,
distributors, and purchasers concerning radiation safety. Correspondence should be reviewed if it involves any
of the following: complaints or concerns about radiation exposure; difficulties with safety components in use or
servicing of the product; investigations made or instructions issued concerning use, adjustment, and repair.

Specifiy the number of letters received from users,dealers, or others about possible radiation
exposure during use of the product, defects or noncompliances.

*

Attach a copy of each letter. Click the Add... button below to attach any supporting files.

File Attachment

Indicate the number of letters received from dealers, distributors, or others concerning the need for
repair, adjustment, or replacement of a part to maintain radiation safety of the product.

*

Attach a summary of correspondence or a sample. Identify any trends in failed components or adjustments needed during
servicing. Click the Add... button below to attach any supporting files.

File Attachment

Indicate the number of notices or brochures sent to users, dealers, or service personnel regarding
defects, noncompliances, or precautions and actions to be taken to maintain radiation safety of the
product.

*

Attach a summary of correspondence or a sample. Click the Add... button below to attach the files.

File Attachment

Part 7 Distribution Records
Provide address of the Production facility that maintains shipping records

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Establishment Information:
Establishment Name
Division Name
FDA Establishment Identifier (FEI)
Central File Number (CFN)
Registration Number
Owner/Operator Number
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Note:
By Model

Indicate how the products can be traced from the records. Check all that apply.
[ ]

By Serial Number

[ ]

By Date of Manufacture

[ ]

Other

[ ]

If you selected the checkbox for Other, please specify

Section: Laser Light Show Report
Laser Light Show Production Tabulation
Item: 1

Accession Number:

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Family Designation of Show:

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Is the laser light show:

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Class:

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Lasing Media:

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Production Status:
Number of shows performed:

*

Active:

*

Product discontinued date:
Number of shows tested for compliance with variance conditions:

*

Error:

You have reached the end of this report. Please verify that all PDFs that are to be included in this submission
are correctly attached to a specific file attachment question. Otherwise, they will not be packaged with your
report. Check to make sure you have no missing data (select Missing Data Report from the Output menu).
Once you have confirmed that there is no missing data and all your files are attached,click on the Package
Submission icon on the tool bar.

Message:

Form FDA 3636 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light
Show Products (03/06)