FDA 3642 General Correspondence

Submission Report

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Submission Report
eRadHealth Menu
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 FDA Electronic
Submission (eSub) software is the next version of the application developed 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.
All electronic reports and correspondence can either be transferred to CD and mailed to the address
below, or can be sent via the FDA Electronic Submissions Gateway to CDRH. If you follow
instructions to set up an account with the FDA Gateway, it currently may take several weeks,, but
when you submit through it you will receive your acknowledgement email message with Accession
Number within minutes! Or, in the interest of faster turn-around for a one-time urgent report of if
you submit few reports, you may simply fill out this template creating the submission and then at
'Packaging' follow the instructions to transfer the files to a CD to mail in. This method of submitting
your report will be acknowledged by an email with the Accession Number within several days.
Information about the FDA Electronic Submissions Gateway can be found at
www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Please contact the
Gateway Helpdesk with your questions about that system.
Electronic submissions on CD should be mailed directly to the Document Control Center at:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Submissions received in the mail on CD will be processed within a few days of receipt.
Note about eSubmitter software:
Instructions provided in this software briefly summarize the requirements of the regulations under
the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product

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Radiation Control, that applies to manufacturers of electronic products that emit radiation. The
software provides questions relevant to requirements in the performance standards and may include
explanations or clarification about the performance, labeling, and informational requirements of the
standard. It does not replace the regulations, however, and if there is any conflict between the
software and the regulations, the regulations must prevail. Throughout this application, pertinent
sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in parentheses.
Please consult them before making design or procedural decisions.
Regulatory requirements for radiological products can be found at http://www.fda.gov/RadiationEmittingProducts/default.htm and for medical devices are located at
www.fda.gov/M/devaDvices/default.htm. If you have specific questions about the regulations,
please contact us at: [email protected].
If you have specific questions regarding this software, please contact the eSub team by email at:
[email protected].
Thank you for using our electronic product reporting software. Please communicate your comments
and suggestions to the eSub team as often as you like.
Thank you for your continued support of the FDA Electronic Submission Program (eSub).
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. The OMB control number for
this information collection is 0910-0025 (expires January 31, 2017).
Role
What is your role?
Information:

!* Manufacturer

The following screen provides several options for you to accurately define what type of
eSubmission you intend to create for FDA. Below are explanations of your options. Please
feel free to review this screen, advance to the next screen and view the picklists, but if you're
confused, come back to read this screen again to be certain you are selecting the correct
report or correspondence type you want to create.

Submission Information
Step 1

Use the radio buttons to identify the type of submission you are preparing.
(Supplements should be prepared using the same document type as the original
submission.)

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
(21 CFR 1002.10)
( ) Annual Report (21
CFR 1002.13)
( ) Laser Light Show
Documents (all relevant
documents) (21 CFR
1040.11(c))
(•) Correspondence

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( ) Variance Request
(General, not Laser Light
Show) (21 CFR 1010.4)
( ) Laser Original
Equipment/Component
Manufacturer Registration
(21 CFR 1040.10(a)(3)(ii))
( ) Abbreviated Report
(21 CFR 1002.12)
Step 2

After answering the Submission Type question above, one of the questions below
may become active and required (see the blue dot to the right of the question). If there
is an active question, select the appropriate product area or document type from the
question's pick list.

What Type of Product is this Radiation Safety Report about?
What Type of Product is this Annual Report about?
What Laser Light Show Document are you filing?
What Type of Correspondence is this?

!*

Inquiry
What Type of Product is this Variance Request about?

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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:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
"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

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Email Address
Establishment Information:
Establishment Name
Division Name
FDA Establishment Identifier (FEI)
Central File Number (CFN)
Registration Number
Owner/Operator Number
D&B D-U-N-S Number
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

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
D&B D-U-N-S Number
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

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Telephone Number
Fax Number

Product Information
Note:

Each product that CDRH regulates is assigned a product code by CDRH. Please provide the
following information regarding the product being reported.

What is the product code?

*

- 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)
Item

Category

Product Code

Performance Standard

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

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Accidental Radiation Occurrence
ARO Introduction
Note:

Accidental radiation occurrences (AROs) must be reported to CDRH by manufacturers
(pursuant to 21 CFR 1002.20), regardless of whether injury occurred, or it was a situation
presenting the potential for injury, or involving a product malfunction. The report must include
identification of the product involved, the circumstances and details of the incident, and
actions taken to prevent recurrence.
If your product is a medical device, an adverse event must be reported using the MedWatch
form and following the Medical Device Reporting regulations explained on the following
website: http://www.fda.gov/cdrh/mdr/.

Model Designation
Note:

Report the model name and/or number, model family, brand name, or other designation of
the product. If reporting a model family, provide the model designation of each model. If you
do not have a model family or brand name, leave the field blank.

Model Designation (Names and/or Numbers):
Item

Model Name

Family Name

*
Brand Name

Description of the Radiation Occurrence
Is this a new Accidental Radiation Occurrence (ARO) report or a
supplement to a previous ARO report?

*

What was the date of the previous ARO report?
Please describe the circumstances surrounding the accidental radiation occurrence, including affected
person(s)' actions when exposed to the radiation, and causes of the occurrence. Please attach any
supplemental files or medical reports by clicking on the Add... button below.

*

Details
If this involves a medical device, has a Medical Device Report (MDR) been
submitted to FDA?

Location of Occurrence
Please provide the physical location where the Accidental Radiation Occurrence took place (eg. at a
residence, a factory, a tanning salon, school, restaurant, airport, etc). If you do not know the exact
address, provide responses to the best of your ability, or enter Unknown. For numerical fields, enter
zeroes if unknown.

*

Establishment Name
Address

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Telephone Number
Please give start and end dates of event. (They may be the
same.)

*

Persons Involved
Please list the number of people exposed in the Accidental Radiation
Occurrence.

*

Please list the number of people adversely affected.

*

Please list the number of potentially exposed people who have not
exhibited any adverse reactions.

*

Please list the number of unexposed people who were involved.

*

Type of reportable event

* [ ] Death

[ ] Serious Injury
[ ] Malfunction
[ ] Other ...

If Other..., specify the the type of event.
Please list the nature and magnitude of exposure and/or injuries.

*

Details
Are the affected person(s) employees of the product manufacturer?

*

Did the affected person(s) have any responsibility toward the operation of the equipment?

*

Remarks

Actions Taken
Actions taken to control, correct, or eliminate the causes and to prevent reoccurrence. If unknown,
please indicate as such in your response.
Please list the actions, to date, taken by the manufacturer in response to the Accidental Radiation
Occurrence.

*

Details
Please list future actions to be taken by the manufacturer in response to the Accidental Radiation
Occurrence.

*

Details

Other Important Information
Please list any other pertinent information and/or attach a file.
Details
Stop:

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

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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.

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Correspondence Details
Model Designation
Note:

If known, report the model name and/or number, model family, brand name, or other
designation of the product. If reporting a model family, provide the model designation of each
model. If you do not have a model family or brand name, leave the field blank.

Model Designation (Names and/or Numbers):
Item

Model Name

Family Name

Brand Name

Additional Information
Please provide an explanation of your actions, concerns, questions, notifications, and/or your requests below.
Details
Stop:

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 (10/31/2013)

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