3637 Laser Original equipment Manufacturer Report

Submission 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?
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

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Section: eRadHealth Menu
Role
What is your role?

* Manufacturer

Submission Information
What Type of Submission is this? (Supplements should be submitted selecting the same document type as the
original report.)
Laser Original Equipment Manufacturer (OEM) Registration Report (Pursuant to 21 CFR 1040.10(a)(3))
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?

What Type of Product is this Variance Request about?

What Laser Light Show Documents are you filing?

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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 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/.

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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
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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

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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
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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

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Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 3 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
Fax Number
Mailing Location:
Address

Responsible Individual
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Note:

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

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Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

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
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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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:
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.)

*

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?

*

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?

*

Provide an explanation:

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

*

A request for an exemption from notification and corrective action?

*

Information on corrective actions you may be conducting?

*

A description of any design changes for future production?

*

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)?

*

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

*

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

*

Request for approval of alternate labeling?

*

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?

*

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

*

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?
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

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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:

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Section: OEM Report
Model Designation
Item: 1

Model Family Designation:

*

Model Designation (Names and/or Numbers):
Item
Brand or Trade Name, if different:
Item
Primary lasing medium or laser type:

*

Primary wavelength (nm):

*

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 3637 Laser Original Equipment Manufacturer (OEM) Report (03/06)

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