Form Approved: OMB No. 0910-0025

Expiration Date: August 31, 2023

FORM FDA 3643 (09/20)

Microwave Oven Products Annual Report

Public reporting burden for this collection of information is estimated to average 18 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:

Department of Health and Human Services 

Food and Drug Administration 

Office of Chief Information Officer 

Paperwork Reduction Act (PRA) Staff 

PRAStaff@fda.hhs.gov

*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 (09/20)
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 (09/20)
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 (09/20)
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:

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.

A. 

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.

B. 

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.

C. 

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 (09/20)
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__.

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.

C.4 PRODUCTION STATUS

FORM FDA 3643 (09/20)
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) (Title)

(Telephone)

( )

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 (09/20)
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 (09/20)
ANNUAL REPORT 

PART 10.0 - YEARLY SUMMARY 

10.1 CURRENT PRODUCTION TABULATION

Accession 

No. Model No. Brand

Oven 

Type

Plant 

Location

No. of 

Units 

Produced

Intro. 

Into 

Commerce 

(mo/yr)

Discontinued 

(mo/yr)

Total:

FORM FDA 3643 (09/20)
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 (09/20)
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

FORM FDA 3643 (09/20)

Model No.

No. of 

Units 

Produced

No. of 

Units 

Sampled

Door 

Condition

Leakage 

Measurements 

Mean 

(mW/cm2)

Leakage 

Measurements 

Std. Dev. 

(mW/cm2)

No. of 

Interlock 

Failures 

Primary

No. of 

Interlock 

Failures 

Secondary

No. of 

Interlock 

Failures 

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: Door closed, Door pulled, Secondary interlock only

No. 

of 

Units 

Tested

320

280

240

200

160

120

80

40

0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 0.1

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

102

50

222

5*

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

210

180

165

10

121

Microwave Leakage (mW/cm2) for model family AB

*Reject limit exceeded by measurement at top edge of door frame because of excessive tolerance 

in new switch bracket

FORM FDA 3643 (09/20)
ANNUAL REPORT 

PART 10.0 - YEARLY SUMMARY

10.3.2 Distribution of Microwave Leakage Audit Data

DOOR CONDITION: Door closed, Door pulled, Secondary interlock only

No. 

of 

Units 

Tested

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

No. 

of 

Units 

Tested

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

. Microwave Leakage (mW/cm2) for model family

*Reject limit exceeded by measurement at 

DOOR CONDITION: Door closed, Door pulled, Secondary interlock only

Microwave Leakage (mW/cm2) for model family

*Reject limit exceeded by measurement at 

FORM FDA 3643 (09/20)
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 (09/20)
ANNUAL REPORT 

PART 10.0 - YEARLY SUMMARY 

10.3.3 Results of Endurance Testing

Model No.

Door 

Condition

Before Test 

Maximum 

Leakage 

(mW/cm2)

During Test 

Maximum 

Leakage 

(mW/cm2)

During Test 

No. of 

Cycles

After Test 

Maximum 

Leakage 

(mW/cm2)

After Test 

No. of 

Cycles

After Test 

No. of 

Cycles at 

Failure

10.4 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 (09/20)
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 (09/20)
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 No

Reporting Period

Jan., Feb., March

April, May, June

July, Aug., Sept.

Oct., Nov., Dec.

Submit not later than

January 1

April 1

July 1

October 1

Accession 

No.

New 

Model 

No. Brand

Oven 

Type

Plant 

Location

Planned Intro. 

Into Commerce 

(mo/yr) Changes

Explanation:

FORM FDA 3643 (09/20)