3642 General Correspondence

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
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.)

*

Correspondence
What Type of Product is this Annual Report about?

What Type of Correspondence is this?

*

Government Agency's Exemption Request
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: Correspondence
Introduction
Information:

This section allows you to submit certain types of information or inquiries that are not part of a manufacturer's
Product Report, Annual Report, or other reports as specified under 21 CFR 1002. However, some
correspondence types would likely be submitted in conjunction with Product Reports. Examples of these
would be Variance requests, Exemption requests, Laser Light Show notifications, follow-ups from FDA
communications and audits, corrective actions, and notifications of product issues.
The following questions may seem a little too vague or not exactly appropriate to your situation but they are
designed to be generic questions to suit many situations and issues. Please respond as well as possible and
you have the opportunity to attach PDF letters or files if you like.

Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 1 hour
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."
Submitter Information
Message:

Please provide the following information regarding the submitter of this report. If you are not associated with a
manufacturing establishment, enter N/A for Establishment Name on the Establishment Identification Tab. If
you are associated with a Government Agency, please complete the Establishment Identification information.

Copy from contact address list
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
FDA Establishment Identifier (FEI)
Central File Number (CFN)
Registration Number
Owner/Operator Number
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Manufacturer Information
Message:

Please provide any information known regarding the manufacturer of the product being reported.

Copy from contact address list
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
FDA Establishment Identifier (FEI)
Central File Number (CFN)
Registration Number
Owner/Operator Number
Physical Location:

*

Address
Telephone Number
Fax Number
Mailing Location:
Address

Product Information
Message:

Please provide the following information regarding the product being reported.

What product type is being reported?
Note:

*

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

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
Describe the product and its intended use. Attach any supporting documents if necessary.
File Attachment
Details

Section: Correspondence Details
Model Designation
Item: 1

Model Family Designation:
Model Designation (Names and/or Numbers):
Item
Brand or Trade Names, if different:
Item

Additional Information
Please provide an explanation of your concerns, your questions, and/or your requests below.

File Attachment
Details
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 3642 General Correspondence (03/06)