FDA 3660 Microwave oven (esubmitter)

3660 Microwave Oven Product Rpt (OMB 0910-0025)
Section: 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 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/Radiation-EmittingProducts/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).

Definitions
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3660 Microwave Oven Product Rpt (OMB 0910-0025)

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:

• 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.
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 ActSec 536 [21 U.S.C. 360mm](d)
Designation of agent for purposes of service
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
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 effect

Role
What is your role?

[L]

Note:

If you are acting as an agent of the actual manufacturer, please select your role as, for example,
perhaps an Importer or Consultant. Later in the report, under Manufacturer Data, you will be
prompted to enter both manufacturer and submitter information.

Information:

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
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.) [QUESTION TYPE NOT YET IMPLEMENTED: HEADER STEP]
What Type of Submission is this?
(Supplements should be submitted
selecting the same document type
as the original report.)

(
(
(
(
(

)
)
)
)
)

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
Variance Request (General, not Laser Light Show) (21 CFR 1010.4)

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
( ) Laser Original Equipment/Component Manufacturer Registration (21 CFR
1040.10(a)(3)(ii))
( ) Abbreviated Report (21 CFR 1002.12)
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. [QUESTION TYPE NOT YET IMPLEMENTED: HEADER STEP]
What Type of Product is this Radiation Safety Report about?
[L]
What Type of Product is this Annual Report about?
[L]
What Laser Light Show Document are you filing?
[L]
What Type of Correspondence is this?
[L]
What Type of Product is this Variance Request about?
[L]

FDA or State Inspector
Abbreviated Report Applicability
OEM Laser Applicability

Section: Manufacturer Data
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
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
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.
Regulatory information is available on the Internet under www.fda.gov/Radiation-EmittingProducts/default.htm. 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 [email protected].
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).

Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 24 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:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
"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 and Report Information
Confirmation:

This Manufacturer section of this report requests names, addresses, phone numbers, etc. for your
firm, various officials of your firm, consultants who may assist in preparing the report, parent firm (if
any), importer and designated agent (for foreign firms). Some of this information is mandatory and its
absence will prevent you from completing the report submission. Because some of these entries may
be redundant, utilize the 'Contact Address Book' feature so you can save your data and reselect the
entries later and in the future. (See the upload/download buttons in upper right corner of the
screens).
You can check for missing data at any time using the "Missing Data Report" from the "Output" menu
across the top of this application. The Missing Data Report lists all missing responses that are
required (that have the blue dot).

Information:

Attention: Variance Applicants
If you are acting as an agent or consultant for, or on behalf of, or filing for, a company that will be
manufacturing or producing a Class IIIb or IV projector or laser light show or both which require an
approved variance, the following explanations may provide further clarification.
Manufacturer: This is the firm or company who is requesting the variance, will certify the product or
show, and will be the holder and owner of the variance. This is not the agent or consultant who may
be filing this report or Variance request for the manufacturer; that agent may be the submitter,
identified in a later screen.
Responsible Individual: This person works for the Manufacturer and is responsible for compliance of
the projector and/or show. In the case of laser light shows, he or she may be the company president,
CEO, or the laser light show head operator or a manager who oversees the shows.
Reporting Official: This person works for the Manufacturer and is responsible for reports,
recordkeeping, and submitting FDA required documents and correspondence.

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: [QUESTION TYPE NOT YET
IMPLEMENTED: ESTABLISHMENT COMPLEX]

Responsible Individual
Note:

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

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Select the Responsible Individual from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED:
CONTACT COMPLEX]

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: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]

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: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]
Internal Reference Number:

Parent Establishment
Is there a parent establishment?

[L]

Select the Parent Establishment and Contact from the Contact Address book: [QUESTION TYPE NOT YET
IMPLEMENTED: CONTACT COMPLEX]

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?

[L]

Written Agreement
Item: 1 (could contain up to 10 items with none required)
Note:

The manufacturer who is certifying the product being reported is the manufacturer of record. If this
firm is not in the United States, please identify your current Importer(s).

Note:

If any of the required responses below do not apply to your designated agent, enter 'NOT
APPLICABLE' or 'NA.'

Select the Designated Agent from the Contact Address book:
Contact Name
Occupation Title
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Email Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
Attach a copy of written agreement with the designated U.S. agent:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Importer
Item: 1 (could contain up to 10 items with none required)
Select the Importer from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]

Additional Manufacturing Locations
Item: 1 (could contain up to 100 items with none required)
Note:

If any of the products certified in this report are manufactured at locations other than listed in the
Manufacturer Responsiblefor Product Compliance section, then the names, addresses, and FDA
registration numbers should be provided. In addition any codes used on labels to identify a
manufacturing location must be provided. Each factory location must assure all production
procedures are followed identically step by step as provided in this report.If the procedures are not the
same then separate reports should be filed.

Select the Manufacturer Address from the Establishment Address book: [QUESTION TYPE NOT YET IMPLEMENTED:
ESTABLISHMENT COMPLEX]
Code used on identification labels:

Section: 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
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
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
Note:

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

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. [QUESTION TYPE NOT YET
IMPLEMENTED: RH SINGLE PRODUCT CODE]
If Other, provide a category name for this specific product.

Examples of Microwave Products
Product Type:

Product Examples:

Microwave Hyperthermia Therapy Devices:

R/F Microwave Hyperthermia Applicator,
Hyperthermia Cancer or Benign Prostatic
Hyperplasia (BPH) Treatment Systems

Microwave Diathermy Machines:

Microwave Diathermy, For Use in Applying
Therapeutic Heat

Microwave Medical Products:

Electrosurgical and Coagulation System with
Accessories, Dental Electrosurgical System,
Endoscopic Electrosurgical (with or without
Accessories), Radio Frequency System for
Refractive Correction, Cranial Magnetic Pulse
Stimulator, Therapeutic Electromagnetic
Stimulator

Microwave Identification, Safety, Security, and
Surveillance Products:

Air Traffic Control, Police Radar, RF
Identification, Electronic Article Surveillance
(EAS), Stun Guns

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3660 Microwave Oven Product Rpt (OMB 0910-0025)

Microwave Ovens (Food Prep):

Microwave Oven, Consumer or Commercial,
Tunnel/Conveyors, Microwave Oven Vending
Machines

Microwave Heating and Drying Products:

Food Processing, Materials Processing, Clothes
Dryer, Medical Waste/Sterilizer

Microwave Communication, Data Transmit, and
Measurement Products:

Walkie-Talkie, Wireless Telephone, CB Amateur
Radio, Microwave Remote Controllers

Other Microwave Products:

RF-Excited Lighting, Microwave Pest Controllers

Report Information
Is this the first time you've submitted a report on the particular type of product selected in the Product Type [L]
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?

[L]

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?

[L]

If you are requesting a renewal, extension, or amendment, please provide the variance number that was
issued by CDRH.
Stop:

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 (General, not Laser Light Show)" as your
Type of Submission in the Submission Information Screen. If you select "Variance Request (General,
not Laser Light Show)r" you must select the product for which you are requesting a variance with the
pick list in the bottom section of the screen.

Special Considerations
Note:

Check all items in this section that may apply to this submission.

Information:

If this product will require a formally approved Variance from a certain performance requirement, you
will need to complete two Reports for FDA, both (1) this Radiation Safety Report (RSR) on this
product, and (2) a Variance Request report. This eSubmitter software application package includes a
general Variance Request form as well as the specific Laser Light Show Variance Request form.
Both the Product RSR file and the appropriate Variance Request Correspondence file must be
submitted to CDRH following the regular files packaging procedures in this application. Both may be
transferred to the same CD or submitted via the FDA ESG to submit to the FDA/CDRH.
In addition, any Variance Request form must be printed out and the signed hard-copy sent to FDA's
Division of Dockets Management at:

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
NOTE: There is no need to send a copy of the CD to Division of Dockets Management.

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

[L]

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

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

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?

[L]

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

[L]

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

[L]

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 "Follow-up correspondence to FDA."

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

[L]

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:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

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)?

[L]

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

[L]

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?

[L]

Request for approval of alternate labeling?

[L]

Application for alternate test procedures (21 CFR 1010.13)?

[L]

You may provide an explanation and/or attach any relevant documents here:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

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 1
Item 2
Item 3
Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details

[HTML Text]

File Attachment

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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
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

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Responses to Communications from FDA
Does this document or any of its attachments contain:
A response to an FDA inspection?

[L]

What was the date of the inspection?

[Date]

A response to a Warning letter or a Notification of Noncompliance or Defect from the FDA?

[L]

What was the date of the Warning Letter or other notification letter?

[Date]

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)?

[L]

What was the date of the inquiry?

[Date]

A response to any other communication from FDA?

[L]

What was the date of the communication?

[Date]

Provide an explanation:
[Multi-Line Plain Text]

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.
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Private Labeling
Is the product sold by other companies under different brand names?

[L]

Private Labeling-Table
Item: 1 (could contain up to 20 items with 1 required)
Give the name and address of the manufacturer:
Establishment Name
Division Name
Email Address
Address
Telephone Number
Fax Number

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Give the firm establishment registration number of the manufacturer listed above (if
known):
Enter brand names and/or model designations in the following table by clicking on the Add button. If you prefer to attach
a file, please click on the Add button and enter the text "See File Attachment" as the first table entry.
Item 1
Item 2
Item 3
List of Brand Names and/or Model Designations
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The Original Equipment Manufacturer (OEM) accession number (if known):
Explain how the brand names and model designations correspond with your own brand names and model designations:
[Multi-Line Plain Text]

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.
[Multi-Line Plain Text]
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.
[Multi-Line Plain Text]
Note:

See also http://www.fda.gov/MedicalDevices/default.htm for more information on medical device
premarket clearance procedures.

Section: Microwave Oven Product
Part 1.0 Model Designation and Specifications
1.1 Identification of Model Family
Provide an identification of a Model Family (Identify by numbers, letters, symbols, or any generic family name that would
represent the models to be listed).

Enter Model designation.
Item 1
Item 2
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Item 3
If you use code for the brand name, please attach a list providing the complete address for each importer or distributor
of each brand and identify the codes used.
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1.2 Magnetron and Waveguide
Please provide photographs and/or engineering diagrams of the waveguide.
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1.3 Mode Stirrer or Equivalent Devices
Item: 1 (could contain up to 15 items with 1 required)
Model Designation
Speed of Stirrer (in RPM)
Speed of Turntable (in RPM)
Number of Blades
Method of Drive
Please provide photographs and/or engineering diagrams of mode stirrer. If your oven does not have a mode stirrer,
please explain in the Details space below:
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1.4 Insertion
Can an insulated wire be inserted through any opening in the external surface of the oven into the cavity,
waveguide, or other microwave energy containing spaces while the door is closed, provided the wire, when
inserted, would consist of two straight segments forming an obtuse angle of not less than 170 degrees?
Warning:

[L]

If you answered yes, your product does not comply with the wire insertion requirement. Please
review the requirement in 21 CFR 1030.10(c)(2)(iv).

Attach clearly labeled photographs or engineering diagrams which show all external surfaces of a fully assembled oven.
Adequate illustrations should demonstrate that it is not possible to insert an insulated wire through any opening in the
external surface into the cavity, waveguide, or other microwave energy containing spaces.
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1.5 Exposed Welds or Seams of the Cavity
Are there any exposed welds or seams of the cavity on the fully assembled oven (such as bottom of oven)?

[L]

Attach clearly labeled photographs or engineering diagrams which show the entire surface of the fully assembled oven
(including underneath).
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1.6 Oven Door
Item: 1 (could contain up to 20 items with 1 required)
Model Designation
The oven door is attached to the main frame by:

[L]

Give a description of your other means by which the oven door is attached to the main frame.
[HTML Text]
Further adjustment or loosening is prevented by (explain):
[HTML Text]
If the door sealing system includes a gasket, which kind is it?

[L]

The type of door latches are:

[L]

If a viewing window is provided, describe its construction and size and the techniques used to control RF emission
through it:
[HTML Text]
Attach photographs or engineering diagrams of microwave emission control door features, hinges, gasket, viewing
screen, choke, door sealing system, door latches, etc.
File Attachment

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1.7 Safety Interlocks and Monitor System
Item: 1 (could contain up to 10 items with 3 required)
Note:

Answer the following questions for one safety interlock or monitor system at a time.

Which safety interlock or monitor system are you describing?

[L]

(Location) - Indicate the location of the safety interlock or monitor system
(Concealment) - Is the interlock or actuator hidden from view (is it concealed)?

[L]

(Wire Insertion) - Can a straight wire or other small thin straight object (10 cm in length or less) operate the
interlock?

[L]

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
(Finger Insertion) - Can a small child's finger operate the interlock or actuator?

[L]

(Interlock adjustment) - Can the switch (or bracket on which the switch is mounted) be adjusted to allow the
interlock to remain in a "closed" position or the monitor to remain open?

[L]

(Actuation distance) - How far can the door be opened before the interlock switch
actuates (fill in number and unit, example, 2 mm )
(Monitored) - Is the safety interlock in the monitoring or crowbar circuit?

[L]

(Door Motion) - Is door motion required to operate this interlock?

[L]

(Sequential Operation) - With the door just opening, number the order of interlock actuation, for example, primary
interlock = first, secondary interlock = second, monitor = third, or primary interlock = first, secondary interlock = same
time as primary, monitor = second.

1.8 Other Requirements
Can a failure of any single mechanical or electrical component of the microwave oven cause all safety interlocks
to be inoperative? [ 21 CFR 1030.10(c)(2)(ii)]

[L]

is there any additional component in the monitor circuit, such as a relay which can disrupt or prevent the function
of the monitor system? [ 21 CFR 1030.10(c)(2)(v)]

[L]

Can interlock failures distrupt the monitoring functions? [ 21 CFR 1030.10(c)(2)(v)]

[L]

Attach schematic and wiring diagram for each model or Model Family. Be sure the required safety interlocks and
monitor are clearly labeled or identified in the schematic or wiring diagram.
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Attach an explanation of how the monitor system works when the safety interlock(s) fail(s) to perform its (their) required
function(s). Be sure to explain the sequence of operation when safety interlock(s) fail(s).
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1.9 Attachments
Attach photographs or engineering diagrams of safety interlocks, monitor and support brackets.
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Attach photographs or engineering diagram of latches (external and internal) in relation to the safety interlocks and
monitor. Be sure to show dimensions of access areas where the latches enter to actuate the safety intelocks and
monitor.
File Attachment

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Attach photographs or engineering diagrams of concealed safety interlock(s) to show how it (they) cannot be activated
by a small child's finger or a straight wire (10 cm in length). Please include dimensions.
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Part 2.0 Labeling Requirements
Information:

21 CFR 1010.2 requires that a legible certification label or tag be permanently affixed and accessible
to view on a fully assembled oven. The following statements are given as examples which satisfy the
requirements of 21 CFR 1010.2:
1. "This oven complies with DHHS Radiation Performance Standards, 21 Subchapter J," or
2. "This product complies with applicable sections of DHHS Federal Performance Standard 21 CFR
1030.10"
21 CFR 1010.3 requires that a legible identification label be permanently affixed and accessible to
view on a fully assembled oven. The identification label should contain the full name and address of
the manufacturer; and the date (month and year) of manufacture must be spelled out completely
without abbreviation. The place of manufacture may be expressed in code provided the manufacturer
has supplied the key to such code to CDRH (as a supplement to the annual report).
21 CFR 1030.10(c)(6)(i) requires that a legible user warning label be permanently affixed and be
readily viewable during normal oven use. This label must also have the title emphasized, and be so
located as to elecit the attention of the user. The exact wording of the user warning label is specified
in 21 CFR 1030.10(c)(6)(i).
21 CFR 1030.10(c)(6)(ii) requires that a legible service caution label be permanently affixed and be
readily viewable during servicing. This label must also have the title "CAUTION" emphasized and be
so located as to elecit the attention of the service personnel. More than one service warning label
may be needed if there is more than one access entry to the internal mechanism of the oven. The
exact working of the service caution label is specified in 21 CFR 1030.10(c)(6)(ii)
21 CFR 1030.10(c)(4) - User instructions or manual - For each model family, submit a representative
draft or final sample of user instructions which will contain adequate instructions for safe use. These
instructions must include the required clear warnings of the "PRECAUTIONS TO AVOID POSSIBLE
EXPOSURE TO MICROWAVE ENERGY ..." statements specified in 21 CFR 1030.10(c)(4).
21 CFR 1030.10(c)(5) - Service Instructions or manual - For each model family, submit a
representative draft or final sample of the service manual. The service manual must contain
adequate instructions for service adjustments and service procedures. These instructions must
include the required clear warnings of the "PRECAUTIONS TO BE OBSERVED BEFORE AND
DURING SERVICING TO AVOID POSSIBLE EXPOSURE TO EXCESSIVE MICROWAVE ENERGY
..." statements as specified in 21 CFR 1030.10(c)(5).

2.1 Labels and Radiation Warnings
Certification label [ 21 CFR 1010.2]: Describe location of the certification label on the product
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Is the label permanent and legible?

[L]

Identification label [ 21 CFR 1010.3 ] : Describe location of the identification label on the product
[HTML Text]
Is the label permanent and legible?

[L]

Is the place of manufacture expressed in code?

[L]

Provide addresses for each code.
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User Warning label [ 21 CFR 1030.10(c)(6)(i) : Describe location of the User Warning label on the product
[HTML Text]
Is the label permanent and legible?

[L]

Service Caution label [ 21 CFR 1030.10(c)(6)(ii) ] : Describe location of the Service Caution label on the product
[HTML Text]
Is the label permanent and legible?

[L]

2.2 Label Attachments
Attach a copy of each of the following labels:
a. Certification label
b. Identification label
c. User warning label
d. Service caution label
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2.3 Attach User and Service manuals
Attach a copy of the draft or final user manual and service manual.
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Section: Technical Data
Part 3.0 Special Tests on Pre-Production Ovens
Information:

For each model family, provide the results of any special or unique tests performed on preproduction
ovens to assure compliance of subsequent production ovens with the Federal performance standard.
The attachment of results of tests on the preproduction ovens should include the following:

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
1. Testing performed to evaluate effects of the environment (heat, humidity, etc.), sensitivity to cavity
temperature, effects of abuse, and the effects of shipping and transporting the oven.
2. Testing to evaluate performance of safety interlocks and monitor switches, door-sealing system,
door choke, and other radiation safety components through life and endurance testing.
3. Testing to evaluate microwave emission characteristics on the external surfaces ( vents, doorsealing system, door choke, underneath the oven, etc.) prior to actuation of safety interlocks and
monitor switches in both normal mode and worse case mode; microwave emission sensitivity to load
placement; and stirrer modulation effects on microwave emission.
The special test should also include results of testing performed on the monitor system ( or crowbar
circuit). The summary of the results should include the conditions of the safety interlocks and monitor
system before and after the tests and description of how the monitored safety interlock(s) was (were)
defeated. The monitor system should render the oven inoperable (such as fuse blowing) and
servicing is required.

3.1Special Tests on Pre-Production Ovens
Attach the results of special or unique tests necessary to evaluate the performance of the safety interlocks, monitor,
microwave emission at all surfaces, transportation testing, life and endurance testing of radiation safety components.
File Attachment

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3.2 Testing of the Monitor System
Attach a description of how the monitor system works when one or both safety interlocks failed, and how the oven is
rendered inoperable.
File Attachment

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Details

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Section: Quality Control
Part 4.0 Incoming Inspection and Subassembly Testing
Message:

Part 4.0 must be completed in its entirety for the Quality Control Report only. Any addenda or
changes to this Part should be reported as a supplement to the Quality Control Report using
appropriate Part D - Supplement to Product Reports. Quality Control Report or Annual Report.
Part 4.0 addresses all applicable quality control and testing procedures for incoming inspection and
subassembly testing of critical radiation safety components which you consider to be a vital and
necessary part of your testing program to ensure compliance of your finished products with the
Federal performance standard 21 CFR 1030.10. This shall include (but not be limited to) incoming
inspection andlor subassembly testing of such items as safety interlocks and monitor switches, wire
harnesses, magnetron gasket, waveguide and cavity assemblies, door and door assemblies, door
sealing system, door viewing screen and noncertified microwave oven modules.
4.1 - For each critical safety component listed on the corresponding form, use as many of the keys to
test parameters identified below as necessary to describe the parameters of each test conducted
during incoming inspection or subassembly testing. In addition, use the notation (100) or (S) to

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
describe whether the tests are done on a "100 percent basis" or "sampling basis." If no tests are done
to the component, use the notation (NT) for "no test."
Keys to Test Parameters:
D = dimension check
E =electrical continuity or performance
F = function test
RF = microwave emission measurement
V = visual inspection
W = weld integrity (destructive or non-destructive)
Example:
Cavities and waveguides: VIS, W/S, DIS
Wire harnesses:NT
Magnetron gasket: V/l00
Microwave oven modules: E/l00, RF/S, F/l00

4.1 Incoming Inspection and Component Tests
Item: 1 (could contain up to 16 items with 8 required)
Select the next component to be described
Message:

[L]

For each test parameters, select the type of test plan used

Dimension check

[L]

Electrical continuity or performance

[L]

4.2 Control of components
Are the incoming components adequately controlled to prevent their use until quality control tests are completed
and lot acceptability is determined?

[L]

Are the rejected lots of components adequately marked or secured so the rejected parts are not used in
production unless reworked?

[L]

Part 5.0 Production Line and Final Tests
5.1 General Tests and Microwave Emission Tests
When are the following tests performed?
Door installation and adjustment checks

[L]

Safety interlocks and monitor continuity function checks

[L]

Microwave emission hazard test over waveguide, cavity seams and magnetron area prior to installing cabinent

[L]

Amount of door travel before secondary safety interlock actuation

[L]

Open door (shut off) operation tests

[L]

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Presence and content of required labels ( such as certification, identification, service and user caution labels)

[L]

Microwave emission test of door viewing screen

[L]

Microwave emission test of door perimeter

[L]

Microwave emission test of door perimeter with door pullled out and all safety interlocks operating

[L]

Microwave emission test of door perimeter with door pulled out and only secondary safety interlocks operating

[L]

Microwave emission test of door hinge, control panel, vents and louvers

[L]

Microwave emission test of underneath the oven (if there is exposed cavity under the oven)

[L]

Microwave emission tests performed by an automated microwave oven scanner

[L]

5.2 Description of Quality Control Checks
Are the written procedures or diagrams available or posted in the working area for the individual performing the
quality control checks?

[L]

Are repaired or adjusted ovens returned to the assembly line at a point prior to the test that caused their
rejection?

[L]

Are all repaired or adjusted ovens, regardless of the nature of the repair, returned to the assembly line for the
open door operation test and final microwave emission tests?

[L]

5.3 Test Procedures
Section 5.3.1. Attach written quality control test procedures for testing continuity of safety interlocks and monitor
switches. You may attach the entire quality control and testing procedures but please indicate where the specific test
procedures are located.
These procedures should include the following:
A) A brief outline of the procedures for function tests of each safety interlock switch (primary and secondary) and
monitor. Also describe electrical continuity checks of each switch along with as much related wiring as possible.
B) A sample schematci with test points identified.
C) A list of instruments and test equipment and description of preoperational checks. Describe any special testing
apparatus or devices.
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Section 5.3.2. Attach written quality control test procedures for performing open door restart operation. You may
attach the entire quality control and testing procedures but please indicate where the specific test procedures are
located.
This open door restart operation test procedure must be performed on every fully assembled oven. An open door
operation test procedure is an excellent quality control test to prevent any oven that will operate with the door open from
being introduced into commerce. The test should incude a check that operation ceases when the door is opened and
an attempt to restart the oven while the door is unlatched. Any signs of microwave power can be monitored by either an
ammeter or RF emission. The restart check should be done with the oven both programmed, and not programmed, for
operation for electronic controller ovens; with and without time on the timer for electromechnanical timer ovens.
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Section 5.3.3. Attach written quality control test procedures for assesing the performance of the secondary safety
interlock. You may attach the entire quality control and testing procedures but please indicate where the specific test
procedures are located.
This section requests written quality control procedures for assessing the performance of secondary interlock design
that interrupt power to the oven (interlock actuates) after the door starts to move. These quality control tests assure that
this secondary safety interlock will prevent "microwave radiation in excess of 5 milliwatts per square centimeter at any
point 5 centimeters or more from the external surface of the oven," as stated in 21 CFR 1030.10(c)(2)(v). If the oven
design employs a latch actuated secondary safety interlock that interrupts power to the oven before there is outward
door movement, this part is not required.
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Section 5.3.4. Attach written quality control test procedures for repair and retesting of defective ovens found on the
production line. You can attached the entire quality control and testing procedures but please indicate where the
specific test procedures are located.
You should describe the following information:
A) A description of all quality control checks done on the repaired or adjusted ovens, such as hazard RF emission,
electrical continuity of safety interlocks and monitor, and tests of any other radiation safety components required to
confirm proper operation.
B) A description of how all ovens set aside for repair and or adjustment re-enter the production line.
C) A sample of the record or form used to retain the model, serial number, nature of defect and repair, and the results
of all retesting conducted.
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5.4 Final RF Emission Testing of Fully Assembled Ovens
Information:

Attach written quality control test procedures for testing continuity of safety interlocks and monitor
switches. You may attach the entire quality control and testing procedures but please indicate where
the specific test procedures are located.

Section 5.4.1 (A) - Physical and electrical conditions under which tests are made (such as line voltage, test load, test
load placement, test load temperature, turntable rotation, power on/off, full power setting, door open, door pulled, door
closed, secondary interlock only RF emission test.
Section 5.4.1 (B) - Adjustment, if any, made during the test and specific procedures and criteria for making adjustments.
Section 5.4.1 (C) - Instruments and test equipment used to make each test, including preoperational instrument checks
and descriptions of any special testing apparatus or devices such as door shims or door pull devices.
Section 5.4.1 (D) - Description of microwave emission measurement procedures, including survery meter scanning
procedures, surface and areas surveyed for RF leakage, scanning speed, and type of spacer probes used to maintain
constatn distance from oven surface.
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Section 5.4.1 (E) - RF reject limit and its basis, such as instrument manufacturer's assessment of calibration error,
stirrer modulation effects, turntable modulation effects, scan speed.
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Section 5.4.2 Provide a sample copy of the record used to retain the results of final emission tests. If an automated
microwave oven scanner (AMOS) is used, inlcude samples for both hand-held testing and AMOS testing.
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Section 5.4.3 Attach a flowchart diagram of the production lines describing the quality control stations, final test areas,
repair bays and audit testing stations.
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Part 6.0 Quality Audit
For each quality control procedures listed, fill in the appropriate sampling rate, or use the notation, "NP" to indicate that
this procedure is not performed in audit. Your sampling rate answer can be similar to any of the following examples:
(ovens per lot), e.g., "20/1000"; (percentage of today's production), e.g. "10%"; (ovens per quarter), e.g., "5/quarter";
(ovens per year), e.g., "4/year"; or (not performed), e.g., "NP".
Safety interlocks and monitor continuity function checks
Microwave emission hazard test over waveguide, cavity seams and magnetron area prior
to installing cabinet
Microwave emission hazard test over waveguide, cavity seams and magnetron area prior
to installing cabinet
Amount of door travel before secondary safety interlock actuation.
Open door (shut off) operation tests.
Insertion test by finger or wire into concealed safety interlock(s) and cavity
Presence and content of required labels (such as certification, identification, service and
user caution labels)
Check for required precaution statements in user and service manuals
RF EMISSION TESTS
Microwave emission test of door viewing screen
Microwave emission test of door perimeter
Microwave emission test of door perimeter with door pullled out and all safety interlocks
operating
Microwave emission test of door perimeter with door pulled out and only secondary safety
interlocks operating
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Microwave emission test of door hinge, control panel, vents and louvers
Microwave emission test of underneath the oven (if there is exposed cavity under the
oven)
Microwave emission tests performed by an automated microwave oven scanner

Part 6.1 Quality Control Procedures Conducted in Audit
Attach a copy of the written quality control test procedures for testing continuity of safety interlocks and monitor switches
and their related wiring.
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Attach copy of written quality control test procedures for performing open door restart operation.
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Attach copy of written quality control procedures for assessing the performance of the secondary safety interlock.
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Are the written procedures or diagrams available or posted in the working area for the individuals performing the
quality control checks?

[L]

Please explain how the firm can ensure that the proper quality control testing procedures are being followed.
[Multi-Line Plain Text]
Attach a sample copy of the record used to retain the results of the quality control checks in audit.
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Part 6.2 Audit Program
Attach a sample copy of the audit record used to retain the results of the quallity control checks in audit, including the
reject limit value for RF emission.
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Attach an internal quality control audit document that contains all oven audit procedures. Include all the equivalent
information requested in Part 5.4.
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
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Attach a copy of the internal quality control document that contains the audit corrective action plan that would be
followed should any ovens selected for audit testing fail to meet the audit test criteria. The description of the audit plan
should include at least the following information:
A. Classification of radisation safety and compliance defects such as excessive RF emission, safety interlocks and
monitor not performing their intended functions, failure of the open door operation check, absence of the required labels,
etc, and their rejection criteria.
B. Plan of action following audit failure, including any resampling.
C. Sample of document or record used to retain test results from corrective action plan including: type of compliance
related defect, sample size, selection, and corrective action or decision taken by responsible or supervisory audit
personnel.
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Part 7.0 Life and Endurance Testing
This Part relates to all applicable life and endurance test procedures to determine the ability of the oven and its
subsequent model family to comply with the Federal performance standard throughout its normal life. Attach the internal
quality control document and a sample of the test results including the following information:
A. Frequency of life testing (weekly, monthly, or quarterly).
B. Test length (short term and long term).
C. Rf leakage tests (start of test, every fixed cycles, and end of test).
D. Rf emission reject limit.
E. Safety interlocks and monitor continuity checks (start of test, every fixed cycles, and end of test).
F. Active Monitor check at end of endurance test.
G. Sample of actual record used to retain the results of life and endurance test.
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Part 8.0 Instrumentation and Calibration Checks
Manufacturers must use properly calibrated microwave leakage measurement instruments in their
production and audit testing and quality control programs to assure compliance with the Federal
Performance Standard for Microwave Ovens, 21 CFR 1030.10. This Part is divided into 5 major
segments. 1. Type of microwave survey instruments aand their measurement errors ( total
polarization ellipticity allowed) 2. Daily Checks and recordkeeping. 3. Thirty-Day calibration
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
constancy checks and recordkeeping. 4. Repair of survey instruments and calibration instruments.
5. Annual calibration and periodic calibration.
8.1 Identification of Compliance Test Instruments
Attach document which provides the name of the compliance survey instrument, model number, and how many are
used in the production department, engineering department and audit department. You can attach a copy of an
operation manual of the compliance survey instrument.
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8.2 Daily Check
Is a preoperational check made on each microwave survey instrument in accordance with the instrument
manufacturer's recommendation?

[L]

Is a polarization ellipse check performed on each instrument each day the instrument is used for compliance
instrument?

[L]

Is the following formula used to calculate the percent of polarization ellipticity of each instrument?

[L]

( MAXIMUM - MINIMUM) / MEAN x 100 = _______(%) TOTAL
What formula is used (type in formula below)? If you prefer, you may attach a file showing the formula for calculating
the percentage of polarization ellipticity of each instrument.
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Is each instrument that is found to exceed the maximum polarization ellipticity limit rejected until the instrument is
repaired and recalibrated?

[L]

During the daily check, is the spacer cone checked on each survey meter and replaced if it is worn or dirty?

[L]

What type of microwave source instrument is used for performing the daily check?
[Multi-Line Plain Text]
Is the probe holding fixture on the daily check instrument designed to prevent any horizontal, vertical and
transverse motion while the probe is being rotated during ellipticity check?

[L]

Is a daily record used to retain the model number, serial number, probe serial number, date of check, percent of
polarization ellipticity, entry for accept/reject criteria, and any other information on the corrective action to to any
instrument that exceeds the limit?

[L]

Attach a sample copy of the sample daily check record for the daily check
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8.3 Thirty Day Constancy Check
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Please provide the manufacturer name and model number of the instrument intercomparison system that is used to
perform the thirty-day constancy check. Please attach a copy of the user operating manual.
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Is a preoperational check made on the LCR in accordance with the instrument manufacturer's recommendation?

[L]

Is the initial reference RF field set by adjusting the RF power level (with the LCR probe positioned at the mean of
its polarization ellipse) until the LCR is reading 1 mW/cm^2 ?

[L]

Which of the following is used to establish the initial reference field (1 mW/cm^2 ) within the 30 day constancy
check system?

[L]

Which of the following is used to re-establish the reference field (1 mW/cm^2) for subsequent constancy checks?

[L]

After the initial reference field (1 mW/cm^2 ) is established, does the technician perform the polarization ellipticity
of the LCR to determine that it does not exceed the maximum polarization limit specified by the instrument
manufacturer?

[L]

Is a thirty-day operational log record used to retain the date of the check, LCR polarization ellipticity (minimum,
maximum, mean, and percentage deviation from mean) and RPM net power readings (RPM difference
readings)?

[L]

Please attach a sample copy of the thirty-day operational log record with data filled out.
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For whichever instrument is used (LCR or RPM) to re-establish the reference field, are the previous readings for
the other instrument compared with the present readings to ensure that they do not differ more than 10 percent
(highest to lowest readings between annual LCR calibration)?

[L]

After the reference field is reset, is the polarization ellipticity of each compliance instrument including the LCR
shown not to exceed the maximum polarization ellipticity limit specificed by the instrument manufacturer?

[L]

After all the compliance instruments have been checked, does the calibration technician perform a selfcomparison check for all similar compliance instruments including the LCR by reviewing or plotting on a graph all
of the minimum and maximum polarization readings since the last annual LCR calibration to ensure that the
LOWEST mimimum reading does not differ from the HIGHEST maximum reading by more than 2 dB?

[L]

Is a 30-day check record maintained including the model number, probe serial number, date of check, LCR and
RPM readings, instrument polarization readings, accept/reject criteria, and repair history for each compliance
survey instrument?

[L]

Please provide a copy of the 30-day record, with data filled out.
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Does the technician maintain a graph plotting the historical mean average values of each compliance instruments [L]
(including the LCR ) to ensure that the instrument's mean values will be within +/- 5 percent of its historical mean
average values?
Please provide a sample graph or table used to record the instrument's historical mean average values.
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3660 Microwave Oven Product Rpt (OMB 0910-0025)
8.4 Repair and Calibration of Compliance Test Instruments
Repair and re-calibration of the microwave survey compliance instruments are performed by the following firm(s):
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Please provide a copy of the written procedures for having instruments repaired and re-calibrated.
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Repair and re-calibration of the LCR, RPM, and any other 30-day calibration instruments are performed by the following
firm(s):
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Each time the LCR or RPM is sent out for calibration or repair, do you begin all of your instrumentation records
again?

[L]

8.5 Annual Calibration and Periodic Calibration
Are the LCR and RPM instruments returned to the instrument manufacturer or other qualified calibration facility
for annual calibration?

[L]

How often are the compliance survey instruments returned to the instrument manufacturer or other qualified calibration
facility for periodic calibration ( at least once every year ) unless they have been sent out for repair and re-calibration?
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Part 9.0 Recordkeeping
Information:

This part requests confirmation that the manufacturer is maintaining records as required by 21 CFR
1002.30 These records basically consist of:
A - Written quality control procedures
B - Quality control test results
C - Life and Endurance test results
D - Copies of written communication between the manufacturer and dealers, distributors and
purchases concerning radiation safety
E - Dealer, distributor, purchaser shipment records.

Are records maintained for the results of tests for the electronic product radiation safety, including control of
unnecessatry secondary or product leakage radiation, the methods, devices and procedures used in such tests,
and the basis for selecting such methods, devices and procedures?

[L]

Are the records maintained of tests for durability and stability of the product?

[L]

Are the results of quality control tests conducted on the production line kept for a minimum of one year after filing
the annual report for these records?

[L]

Are the quality control audit records, documentation of defective ovens found in audit and the results of audit
reaction plan kept for minimum of five years?

[L]

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3660 Microwave Oven Product Rpt (OMB 0910-0025)
Is a file maintained of all written communications between manufacturer, dealers, distributors, and purchasers
concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use,
repair, adjustment, maintainence or testing of the microwave oven manufactured by your company?

[L]

Where is the file located?

Is a file maintained of records necessary for tracing of microwave ovens to distributors, dealers and purchasers?

[L]

Have all the dealers and distributors been informed of their obligations or requirements to obtain the information
required by 21 cfr 1002.4(b) (purchaser information) in order to permit tracing of specific products to specific
purchasers?

[L]

Manufacturer can trace shipment to dealers/distributors or purchasers by:

[
[
[
[

]
]
]
]

Model number
Serial number
Date of manufacture
Other:

Please specify other methods

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 3660 Microwave Oven Product Report (10/31/2013)

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