FDA 3643 Microwave Oven Products Annual Report

Form Approved: OMB No. 0910-0025
Expiration Date: January 31, 2017

FORM FDA 3643 (3/14)
Microwave Oven Products Annual Report

Public reporting burden for this collection of information is estimated to average 26.5 hours per
response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and 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:
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Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
*Please do NOT send your completed document to this PRA Staff email address.*
An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number.

This guidance was written prior to the February 27, 1997 implementation of FDA’s
Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person
and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statute, regulations, or both.
This guidance will be updated in the next revision to include the standard elements of GGP’s.

More industry guidance and assistance can be found at the FDA homepage, see:
http://www.fda.gov/Radiation-EmittingProducts/.

Send your completed report to:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
Questions about reporting and suggestions for changes to this report may be sent to the
above address or may be discussed by calling 1-800-638-2041.

FORM FDA 3643 (3/14)

Microwave Oven Products
Annual Report

March 1985

This report replaces the March 1974 edition and incorporates the
June 1983 Annual Report Guide.
The reporting and/or recordkeeping requirements contained herein have been approved by the Office of
Management and Budget in accordance with the Paperwork Reduction Act of 1980 (OMB Approval No.
0910-0025).

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Silver Spring, MD 20993

FORM FDA 3643 (3/14)

GENERAL INFORMATION
The Microwave Oven Products Annual Report provides microwave oven manufacturers
and importers with guidelines and uniform formats for submitting information on the
certification of microwave ovens subject to the Federal performance standard under the
Radiation Control for Health and Safety Act of 1968 (P.L. 90-602). Microwave oven
manufacturers are required to submit Initial Reports, Model Change Reports, Annual
Reports, and Report Supplements to the Center for Devices and Radiological Health
(CDRH) as mandated by Title 21 CFR 1002.10, 1002.11, and 1002.12.
This new report supersedes the March 1974 version and incorporates the June 1983
Annual Report Guide. Most of the forms in this report have been revised and simplified
from the March 1974 edition. The new format is intended to provide manufacturers and
importers with a clear understanding of the specific information required by CDRH.
These reporting forms will provide CDRH with product information and an adequate
explanation of how manufacturers' quality control and testing programs are utilized to
assure that the microwave ovens comply with all applicable sections of the Federal
performance standard prior to introduction into United States commerce.
SAVE THIS REPORT AND USE IT FOR PHOTOCOPYING. You should duplicate the
forms in this report for inclusion in your report and retain a copy of the completed report
for your records. Proprietary information should be specifically and clearly marked.
Information submitted in your report will be used to evaluate your quality control and
testing program, identify potential safety problems, and make decisions on the level and
type of monitoring programs to be conducted by FDA, such as product testing and factory
inspections.
Upon receipt of your reports, the Center for Devices and Radiological Health
(CDRH) will send you an acknowledgment letter with an Accession Number which you
should reference when you submit additional information. You will receive further
notification only if additional information or clarification is needed. Send your completed
reports to:
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
ATTN: ELECTRONIC PRODUCT REPORTS
Center for Devices and Radiological Health
Silver Spring, MD 20993

REMINDER
ACCIDENTAL RADIATION OCCURRENCES
You are required by 21 CFR Subchapter J, Section 1002.20, to immediately report
accidental radiation occurrences. Report to the Director, Center for Devices and
Radiological Health, all accidental radiation occurrences reported or otherwise known to
you and arising from the manufacture, testing, or use of any product you have introduced,
or intend to introduce, into commerce.

ii
FORM FDA 3643 (3/14)

DEFINITIONS
Initial Report: The first report submitted by a manufacturer in a regulated product area,
e.g., microwave ovens. The Initial Report consists of a PRODUCT REPORT that
describes the product and identifies its radiation safety features and a QUALITY
CONTROL REPORT that explains the quality control and testing program to assure
compliance (21 CFR 1002.10). Upon receipt of the PRODUCT REPORT and the
QUALITY CONTROL REPORT, the Center for Devices and Radiological Health
(CDRH) will assign each a seven-digit Accession Number which is used to locate the
reports in the CDRH file system. CDRH will then send a letter to the corresponding
official of the manufacturer or importer; this letter will acknowledge receipt of the
reports and will list their Accession Numbers.
Model Family: A group of two or more microwave oven models that are basically similar
in design and performance features, particularly those relating to radiation safety. Ovens
within the same Model Family may have slight variations in such areas as power output,
control panel features, or circuitry. Such ovens are manufactured under the same, or very
similar, quality control and testing procedures. Each Model Family is described in a
separate PRODUCT REPORT.
Model Change: When a microwave oven with a new model number is produced, it should
be reported in one of the following ways:
A.

If a new model is significantly different from all previously reported models in
regard to radiation safety components or radiation safety performance (e.g.,
door-choke design, door-sealing system, cavity configuration, mode stirrer,
location of safety interlocks or monitor switches), a new PRODUCT REPORT
must be filed before the new model is introduced into commerce. This
PRODUCT REPORT must describe that model, which will be the first in a new
Model Family. If quality control and testing procedures for the new model are
different from those previously described in the QUALITY CONTROL
REPORT, the changes must be described in a REPORT SUPPLEMENT to the
QUALITY CONTROL REPORT.

B.

If a new model is basically the same as a previously reported model (i.e., the new
model is part of the same Model Family), the PRODUCT REPORT for the previous
model must be updated, before the new model is introduced into commerce, by a
REPORT SUPPLEMENT which details the differences. Any changes in quality
control or testing procedures resulting from the new model must be described in a
REPORT SUPPLEMENT to the QUALITY CONTROL REPORT.

C.

If a new model is the same as a previously reported model in all aspects of radiation
safety (i.e., only the selling model number has changed), the ANNUAL REPORT
must be updated in a quarterly REPORT SUPPLEMENT.

Annual Report: A summary of records covering the 1-year period July 1 to June 30, to be
submitted to CDRH on or before September 1 of each year. Public Law 90-602, the
Radiation Control for Health and Safety Act of 1968, requires that manufacturers of
electronic products establish and maintain records, and provide performance data, on
radiation safety and provide information on their quality control and testing programs.
Report Supplement: Additions, deletions, corrections, or changes to information previously
submitted in a PRODUCT REPORT, QUALITY CONTROL REPORT, or ANNUAL
REPORT. REPORT SUPPLEMENTS reference the CDRH Accession Number and
submission date of the previous report.
iii
FORM FDA 3643 (3/14)

INSTRUCTIONS: PART C - ANNUAL REPORT
C.1 AND C.2 MANUFACTURER/IMPORTER IDENTIFICATION
Fill in the requested information and sign where indicated. Fill in the years in the
reporting period. Example: The report due every September 1 should cover the reporting
year July 1, 20__, through June 30, 20__.

C.4 PRODUCTION STATUS
Check the statement that applies to your firm. Complete all of Part 10.0, or Part 10.4 only,
as indicated after the statement you have checked.

FORM FDA 3643 (3/14)

PART C - ANNUAL REPORT
C.1 MANUFACTURER
Company Name:
Address:

This Annual Report is submitted in accordance with 21 CFR 1002.11 for the period July 1, 19__
through June 30, 19__ .
Corresponding Official:
(Signature)
(Name)
(

)
(Telephone)

(Title)
Email

C.2 IMPORTER (if applicable)
Company Name:
Address:

Corresponding Official:
(Signature)
(Name)
(

(Title)

)
(Telephone)

Email

C.3 DATE OF THIS ANNUAL REPORT:
C.4 PRODUCTION STATUS
Products were manufactured during this period, and the firm is still in business. All of Part 10.0
has been completed.
No products were manufactured during this period, but the firm is still in business and expects
to manufacture in the future. Only Part 10.4 has been completed.
No products were manufactured during this period, and the firm is now out of business.
Only Part 10.4 has been completed.
Products were manufactured during this period, but the firm is now out of business.
All of Part 10.0 has been completed.

FORM FDA 3643 (3/14)

INSTRUCTIONS
ANNUAL REPORT
PART 10.0 - YEARLY SUMMARY
10.1 CURRENT PRODUCTION TABULATION
Provide production data, using the form or a comparable tabulation. If additional space is needed, use
another copy of the form and label it Part 10.la, 10.1b, etc., on each page.
"Accession Number": For previously reported models, CDRH will have assigned this number and
reported it to you.
"Brand": You may use a code for each brand in the chart. On a separate sheet, provide the complete
address for each importer or distributor of each brand and identify any codes. Label the sheet
Part 10.1.
"Oven Type": Indicate whether the model is common cavity (COM), countertop commercial (CTC),
countertop domestic/household (CTD), high/low or over/under (HLO), module (MOD), wall hanging
oven (WHO), built-in single oven (BSO), built-in double oven (BDO), or under-the-cabinet oven
(UTC).
"Plant Location": Codes may be used. On a separate sheet, provide the complete address for each
manufacturing location and identify any codes. Label the sheet Part 10.1.
"Discontinued (mo/yr)": Provide discontinuation date for any model that is no longer in production
but was produced at some time during the reporting period.

FORM FDA 3643 (3/14)

ANNUAL REPORT
PART 10.0 - YEARLY SUMMARY
10.1 CURRENT PRODUCTION TABULATION

Accession
No.

Model No.

Brand

Oven
Type

Plant
Location

Total:

FORM FDA 3643 (3/14)

No. of
Units
Produced

Intro.
Into
Commerce
(mo/yr)

Discontinued
(mo/yr)

INSTRUCTIONS
ANNUAL REPORT
PART 10.0 - YEARLY SUMMARY
10.2 PROCEDURES FOR QUALITY CONTROL AND TESTING
You are required by 21 CFR 1002.30(a) (1) and (2) to maintain written procedures for quality control
and testing. The procedures in use and those submitted in the Quality Control Report should be
reviewed and updated.
Compare your current procedures with those submitted in your Quality Control Report. Check the
appropriate answers and take any indicated action.

10.3 SUMMARY OF TEST RESULTS
You are required by 21 CFR 1002.30(a)(2) to maintain results of quality control tests. For each
microwave oven product introduced into commerce, you should evaluate test results to be certain that
the total program is adequate to assure radiation safety and compliance with the standard (21 CFR
1030.10).
10.3.1 - Results of Audit Tests
Complete the table or provide comparable data on a separate sheet and label it Part 10.3.1.
"Door Condition": Indicate the door condition during tests, using these codes:
(C) = door in the normal closed position with all interlocks operating;
(P) = door pulled against any mechanical stops with all interlocks operating;
(S) = door pulled against any mechanical stops with only the secondary interlock operating.
The interlock design of some models requires that leakage measurements be made under more
than one door condition. Provide data for measurements made under each door condition.
"No. of Interlock Failures": Provide identification of failed switches and a description of the failure.
(Use a separate sheet and label it Part 10.3.1.)
"No. of Units Rejected": For each unit rejected in audit testing because of failure to conform to
microwave radiation safety specifications, describe the reason for rejection and the actions taken to
determine if other units in that lot or in other lots had the same problem. (Use a separate sheet and
label it Part 10.3.1.)

FORM FDA 3643 (3/14)

ANNUAL REPORT
PART 10.0 - YEARLY SUMMARY
10.2 PROCEDURES FOR QUALITY CONTROL AND TESTING
The internal quality control written procedures for assessing and controlling radiation safety have
been reviewed. (These include prototype testing, incoming materials testing, assembly testing,
retesting after repair, and service testing.) The procedures for maintaining quality control testing
equipment have also been reviewed. All procedures are up-to-date, complete, and accurate.
Yes

No

Are the written quality control procedures you have submitted to CDRH up-to-date, complete, and
accurate?
Yes

No

If either question is answered No, provide the current procedures in a supplement to the appropriate
quality control report.
10.3. SUMMARY OF TEST RESULTS
10.3.1 Results of Audit Tests
Leakage
Measurements

No. of Units
Model
No.

FORM FDA 3643 (3/14)

Produced

Sampled

Door
Condition

Mean
(mW/cm2)

Std.
PriDev.
(mW/cm2) mary

No. of Interlock
Failures
Secondary

Monitor

No. of
Units
Rejected

INSTRUCTIONS
ANNUAL REPORT
PART 10.0 - YEARLY SUMMARY
10.3.2 - Distribution of Microwave Leakage Audit Data
Analyze microwave leakage audit data. Use bar graphs to summarize the maximum levels;
include only one model family (with a common accession number) in each graph.
Above each graph, check the appropriate door condition; at the bottom, indicate the model family
designation. Label the side of the graph to show the number of units tested; label the bottom to show
the upper limit of each range of measurement. Then draw in the bars to represent the distribution of
measurements, and mark the reject limit with a dotted line.
If more than 2 graphs are needed, use additional photocopies of the form and label them Part 10.3.2a,
10.3.2b, etc., on each page.
If any measurements exceed the reject limit, identify them with asterisks (*) and indicate beneath the
graph the area of the oven where the leakage was found and the reason for the leakage. On a separate
sheet labeled Part 10.3.2, provide: (1) an analysis of the problem; (2) a description of the actions
taken to correct the problem; and (3) a summary of the data from any additional testing.
Example:
DOOR CONDITION:

320
280
No.

240

of
Units
Tested

200
160
120
80
40

..
..
..
..
..
..
..
..
..

0.0

Door closed,

Door pulled,

222
180

210
165
121

102
50
10
0.1

0.2

0.3

0.4

Microwave Leakage (mW/cm2) for model family
*Reject limit exceeded by measurement at
in new switch bracket
FORM FDA 3643 (3/14)

Secondary interlock only

0.5

0.6

0.7

..
..
..
..
..
..
..
..
.
0.8

5*
0.9

AB

top edge of door frame because of excessive tolerance

0.1

ANNUAL REPORT
PART 10.0 - YEARLY SUMMARY
10.3.2 Distribution of Microwave Leakage Audit Data
DOOR CONDITION:

No.
of
Units
Tested

..
..
..
..
..
..
..
..
..
.

Door closed,

Door pulled,

Secondary interlock only

..
..
..
..
..
..
..
..
..
.

Microwave Leakage (mW/cm2) for model family
*Reject limit exceeded by measurement at

DOOR CONDITION:

No.
of
Units
Tested

..
..
..
..
..
..
..
..
..
.

Door closed,

Door pulled,

Microwave Leakage (mW/cm2) for model family
*Reject limit exceeded by measurement at
FORM FDA 3643 (3/14)

Secondary interlock only

..
..
..
..
..
..
..
..
..
.

INSTRUCTIONS
ANNUAL REPORT
PART 10.0 - YEARLY SUMMARY
10.3.3 - Results of Endurance Testing
You are required by 21 CFR 1002.30(a)(3) to maintain results of endurance testing. Summarize tests
on prototypes and on final products to show how extended use can affect radiation safety, or provide
comparable data on a separate sheet and label it Part 10.3.3.
"Door Condition": Indicate if door was closed (C), in a pulled position with all interlocks
operating (P), or open to the position where only the secondary interlock is operating (S). If a
model number is tested under more than one door condition, be sure to enter data in each column
for each condition.
On a separate sheet labeled Part 10.3.3, identify each component that failed or required readjustment
as a result of life or endurance testing and that could affect the quality or distribution of microwave
leakage. Include interlock and monitor switch failures, and the means employed to correct each
failure.

10.4 CORRESPONDENCE CONCERNING RADIATION SAFETY
You are required by 21 CFR 1002.30(a)(4) to maintain copies of communication to or from dealers,
distributors, and purchasers concerning radiation safety. Correspondence should be reviewed if it
involves any of the following: complaints or concerns about radiation exposure; difficulties with
safety components in use or servicing of the product; investigations made or instructions issued
concerning use, adjustment, and repair.
Fill in the number of documents sent or received and attach the copies, summaries, or samples as
indicated.
NOTE: This summary does not replace the notification requirements for potential defects or
noncompliances under 21 CFR 1003.10 or for suspected accidental radiation occurrences under 21
CFR 1002.20.

10.5 DISTRIBUTION RECORDS
You are required by 21 CFR 1002.30(b)(1) and (2) to maintain distribution records. Such records
must allow tracing of products to the dealer and, if possible, to the user.

FORM FDA 3643 (3/14)

ANNUAL REPORT
PART 10.0 - YEARLY SUMMARY
10.3.3 Results of Endurance Testing
Before Test
Model
No.

10.4

Door
Condition

Maximum
Leakage
(mW/cm2)

During Test
Maximum
Leakage
(mW/cm2)

No. of
Cycles

After Test
Maximum
Leakage
(mW/cm2)

No. of
Cycles

No. of
Cycles at
Failure

CORRESPONDENCE CONCERNING RADIATION SAFETY

The number of letters received from users, dealers, or others about possible radiation exposure or
interlock failures during use of the product was
.
If the complaint did not clearly result from steam or a hot utensil, a copy of each letter is
attached behind this page and labeled Attachment 10.4.
The number of letters received from dealers, distributors, or others concerning the need for repair,
adjustment, or replacement of a part to maintain radiation safety of the product was
.
A summary of correspondence, or a sample, is attached behind this page and labeled
Attachment 10.4. Any trends in failed components or adjustments needed during
servicing are identified.
The number of notices or brochures sent to users, dealers, or service personnel on precautions or actions
to be taken to maintain radiation safety of the product was
.
A summary of correspondence, or a sample, is attached behind this page and labeled
Attachment 10.4.
10.5 DISTRIBUTION RECORDS
Production facility shipping records and dealer records (when returned) are
maintained at:
FORM FDA 3643 (3/14)

.

INSTRUCTIONS
ANNUAL REPORT
PART 11.0 - QUARTERLY UPDATE OF NEW SELLING MODELS
New model numbers added to a previously reported model family may be reported in a supplement to
the current Annual Report if the information in the Product Report is still applicable. If you are
reporting new or modified ovens with new electrical, cosmetic or mechanical changes that COULD
NOT affect the RF leakage characteristics or function of the safety interlocks and monitor, this form
can be used in the same manner. It is recommended that these new models be reported on a quarterly
basis. Changes that may be reported in a new model report supplement include:
(a) = cosmetic changes
(b) = new brand names
(c) = control panel changes
(d) = addition of a temperature probe feature
(e) = changes in areas of the circuitry that could not affect the RF characteristics or the
function of the safety interlock(s).
Note: If the current written quality control and testing procedures are not applicable to the new
models, then a supplement to the Quality Control Report, containing updated quality control and
testing information, must be submitted (see Instructions: Part D - Supplement to Product Reports,
Quality Control Report or Annual Report).
Use the accompanying form or a comparable tabulation. If additional space is needed, use another
copy of the form or attach a separate sheet and label it 10.6a, 10.6b, etc.
Check the appropriate answer to the question and check the reporting period for which the report
supplement is being filed.
"Accession Number": Provide the accession number of the Product Report for the basic oven design
family that closely resembles the new models.
"Brand": You may use a code for each brand in the chart. On a separate sheet, provide the
complete address for each importer or distributor of each brand and identify any codes. Label the
sheet 11.1.
"Oven Type": Indicate whether the model is common cavity (COM), countertop commercial (CTC),
countertop domestic/household (CTD), high/low or over/under (HLO), module (MOD), wall
hanging oven (WHO), built-in single oven (BSO), built-in double oven (BDO), or under-the-cabinet
oven (UTC).
"Plant Location": Codes may be used. On a separate sheet, provide the complete address for each
manufacturing location and identify any codes. Label the sheet 11.2.
"Changes": State the model number of the old model that is most similar to the new model. Using
codes (a) through (e) for the changes listed above, indicate the changes made in the new model.
"Explanation": Additional space is given to allow explanation for brand names, oven types, or other
pertinent information.
NOTE: If the new models contain any changes that could affect the RF leakage characteristics or the
function of the safety interlock(s), which could result in the evolution of a new model family, the new
model number(s) and the details of the change(s) must be submitted as a Product Report. If there are
any questions in this regard, please contact CDRH prior to reporting.
FORM FDA 3643 (3/14)

ANNUAL REPORT
PART 11.0 - QUARTERLY UPDATE OF NEW SELLING MODELS
The current written quality control and testing procedures for assessing and controlling radiation
safety have been reviewed and are applicable to the new models listed below.
Yes
Reporting Period

Submit not later than

Jan., Feb., March

January 1

April, May, June

April 1

July, Aug., Sept.

July 1

Oct., Nov., Dec.

October 1

Accession
No.

Explanation:

FORM FDA 3643 (3/14)

New
Model
No.

Brand

Oven
Type

Plant
Location

Planned Intro.
Into Commerce
(mo/yr)

Changes

No