FDA 3633 General Variance Application

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?
What Type of Product is this Variance Request about?

!*

Microwave Oven Products

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Manufacturer Data
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.
Be sure to enter address information for each tab below:

Select the Manufacturer's address from the Establishment Address book:

*

Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

Responsible Individual
Note:

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

Select the Responsible Individual from the Contact Address book:

*

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

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Mailing Location:
Address
Telephone Number
Fax Number

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.

Select the Reporting Official 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
Telephone Number
Fax Number

Report Submitter
Note:

The submitter may be a consulting individual or firm providing assistance in report
preparation and maintenance. Documents or submissions such as this one that are prepared
by the submitter must have an accompanying authorization letter from the manufacturer's
reporting official for authenticity.

Select the Submitter from the 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
Telephone Number
Fax Number
Comments:
Internal Reference Number:

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?

*

Importer

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Product Data
Product and Model Identification

Attention - Information about this section
In this section you'll be asked to identify several required or optional things which will help
FDA/CDRH staff to prioritize their reviews. You'll be asked to consider the following aspects:
(1) Identify your product's radiation type and the CDRH Product Code.
(2) Enter an Accession number if this will be a report supplment. If you are preparing a supplement,
you'll see that after entering a valid 7-digit Accession number many questions will no longer be
required (they will either be disabled or will be optional, meaning they will no longer have the blue
dot).
(3) You will also have several questions that are of high significance for FDA/CDRH - why you
might be submitting this report or correspondence. Please read these questions carefully, referring to
the 21 CFR regulations on the website www.FDA.gov if you are unsure if the question is relevant to
your firm's situation.
(4) If you find that you have more information that you want the FDA/CDRH to read but it doesn't
seem to fit under other questions, we have a final "Additional Information" question in this section
which invites you to add comments and/or attach a file that provides further information from your
firm about this submission. This is the place to add that extra information.

Product Type Reported
What is the product code?

*

To select the three letter product code,
- Click the plus sign. You will see a product code filter dialog box.
- Select the appropriate category name from the pick list. You will be provided a list of product codes
from which to choose.
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code.
Category
Product Code
Performance
Standard
If Other, provide a category name for this specific product.

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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 original report for which this is a supplement:
(Note: Do not enter any Device Premarket Application or Notification document number here,
such as PMAs, 510(k)s, IDEs, etc. See Accession number description below.)
Are you requesting a new variance, a renewal, extension or amendment to a
previous variance?

*

If you have a Docket Number that was issued by FDA's Division of Dockets
Management, please provide it here.

Special Considerations

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

*

You may provide an explanation and/or attach a document here:
Details

Responses to Noncompliances or Defects
Does this document or any of its attachments contain any of these responses concerning
noncompliances or defects?
A refutation of noncompliances or defects identified to your firm?

*

A request for an exemption from notification to purchasers (see 21 CFR 1003.21 and 1003.30)?

*

Corrective action plans you intend to implement to correct noncompliances or defects discovered in
past or current production?

*

Note:

If you are submitting a Corrective Action Plan (CAP) following 21 CFR 1004 and information
on design changes for future production, the design change information must be submitted in
a Radiation Safety (Product) Report or supplemental report. Both the proposed CAP and the
design changes may be submitted in one document if you prepare a product report and
choose to include the CAP in it as a file attachment. Alternatively, you may create a separate
eSubmission for the CAP using the "Correspondence" type template and selecting "Followup correspondence to FDA."

A description of any design changes that correct noncompliances for future production?

*

Note:

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If you are submitting information on product design changes for future production due to a
discovery of noncompliances or defects in current production, you must use the Radiation
Safety (Product) Report template to create the report . Correspondence templates may be
used to submit other information such as a proposed corrective action plan pertaining to a
noncompliance or defect.
You may add an explanation and/or attach a document here:
Details

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (21 CFR 1010.5)?

*

Exemption for products for government use from reporting and recordkeeping (21 CFR 1002.51)?

*

Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?

*

Request for approval of alternate labeling?

*

Application for alternate test procedures (21 CFR 1010.13)?

*

You may provide an explanation and/or attach any relevant documents here:

Variance Requests
Information:

Please note: in addition to responding to these questions below, a separate General
Variance Request or Laser Light Show Variance Request form must be completed and
submitted to CDRH, with a hard copy sent to FDA's Division of Dockets Management as
instructed below for any variance request. The information requested on this screen does not
constitute the full structured content of the variance request. The 2 types of Variance forms
can be created in eSubmitter by selecting the appropriate Variance submission type under
the eRad Health Menu section of this application.

Message:

Click the plus sign to list the requirements from which you are requesting a variance.

This submission includes an application for a variance from certain requirements.
Item

No Information Provided.

Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details
Stop:

For all Variance requests, two submissions must be made to the FDA.
The electronic version should be submitted following the Packaging Files for Submission
instructions located under Output in the Menu bar, and explained in subsection 4.3 of the
User Manual. If sending a CD & submittal letter, please mail 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

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Additionally, a paper version (hard-copy) of the signed Variance request document should be
submitted to:
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20857

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

*

What was the date of the inspection?
A response to a Warning letter or a Notification of Noncompliance or Defect from the
FDA?

*

What was the date of the Warning Letter or other notification letter?
A response to a report review inquiry from the 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?

*

What was the date of the communication?
Provide an explanation:

Additional Information
Here's your opportunity to add anything else to this submission that you want to tell the FDA!
Is there any other relevant information or additional comments that would help expedite the review of this
submission? Click the plus sign below to attach any supporting files.
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.

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If it has not been submitted yet, or if your device is exempt from premarket clearance or approval, please
provide an explanation. The device regulations can be found in 21 CFR 807 - device manufacturer
registration and device listing.

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General Variance Request
Model Designation
Enter the Model Designation (Name and/or Number). If you do not use a Model Family or Brand Name,
leave the field blank.
Item

Model Name

Family Name

*

Brand Name

Intended Use and Variance Description
Describe the product and its intended use.

*

Details
Explain how compliance with the standard would restrict or be inappropriate for this intended use.
Please attach any additional information if necessary.

*

Details
Describe the manner in which it is proposed to deviate from the requirements of the applicable standard.
Attach any supporting files if necessary.

*

Details

»

Describe the advantages to be derived from such deviation.

*

Details

Radiation Protection and Variance Duration
Provide a detailed explanation of how alternate or suitable means of radiation protection will be
provided. Click on the Add... button below to attach any supporting files.

*

Details
Provide the period of time it is desired that the variance be in effect.

*

If "Other" has been selected, please specify further.
If appropriate, provide the number of units the applicant plans to manufacture.

Prototype or Experimental Design
Is the product a prototype or experimental design?

*

Remarks

Proposed Location

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Renewal, Extension or Amendment of Variance
Select the number of years for which you are requesting the renewal, extension or
amendment.

*

If "Other" has been selected, please provide the length of time for which you are
requesting the renewal, extension or amendment.
List the number of units the extended variance will cover.
Give a further detailed explanation of the basis for the renewal, extension or amendment request. Click
on the Add... button below to attach any supporting files.

*

Details
Describe the effect of the renewal, extension or amendment on protection from radiation produced by
the product. Click on the Add... button below to attach any supporting files.

*

Details

Certification
The manufacturer certifies the following:

*

All of the above information and statements are true, complete, and correct to the best of my
knowledge. The manufacturer acknowledges that the variance application may be denied or the
variance may be revoked if this application is found to be false, misleading or incorrect in any material
way. The manufacturer has submitted and will submit all reports required by 21 CFR Part 1002. The
manufacturer further understands that they may be required by regulation or by the Director, Center
for Devices and Radiological Health, to supply such other information as may be necessary to
evaluate and act on this application.
Copy from the contact address book.
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

Packaging Instructions
Stop:

For all Variance requests, two submissions must be made to the FDA.
The electronic version should be submitted following the Packaging Files for Submission
instructions located under Output in the Menu bar, and explained in subsection 4.3 of the
User Manual. If sending a CD & submittal letter, please mail to:
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-G609
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Additionally, a paper version (hard-copy) of the signed Variance request document should be
submitted to:
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Note:

In a few weeks you should receive a Docket number from Dockets Management and a
Variance number from CDRH. Both of these numbers may be saved with this report in the
following procedure:
1. Reopen this report
2. Click on the File Menu and select Properties
3. In the Comments field, you may enter these identifying numbers and any other pertinent
information for future reference.

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.

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