Form Approved: OMB No. 0910-0025

Expiration Date: February 28, 2026

FORM FDA 3663 (06/23)

Abbreviated Reports on Radiation Safety for 

Microwave Products (Other than Microwave Ovens)

Public reporting burden for this collection of information is estimated to average 5 hour 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 

Paper 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 guide may be sent to the above 

address or may be discussed by calling 1-800-638-2041.

FORM FDA 3663 (06/23)
ABBREVIATED REPORTS ON RADIATION SAFETY 

FOR MICROWAVE PRODUCTS 

(OTHER THAN MICROWAVE OVENS)

AUGUST 1995

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration 

Center for Devices and Radiological Health 

Silver Spring, MD 20993

FORM FDA 3663 (06/23)
Foreword

The Office of Compliance, Center for Devices and Radiological Health (CDRH) developed this guide. This guide will 

assist manufacturers1 of electronic products which 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 requirements2,3.

Reports submitted on radiation safety of electronic products must follow the appropriate guide (21 CFR 1002.7). If the 

report does not follow an applicable guide it must contain a sufficient justification for any deviations. The submitter of 

the report will receive an acknowledgment letter with the accession number we assign to the report. Please reference this 

accession number in the future when providing 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. Also, a rejected report will not receive an accession number.

WE DO 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 report and to comply with all applicable importation requirements 

(21 CFR 1005). If there are deficiencies, we 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. We 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 (21 CFR 1003 - 1004) for products 

already introduced into commerce.

Please mail your reports to the address below (FDA can not process electronic submissions at this time). Provide the 

original report with appropriate signature(s) (no facsimiles, please). Provide extra copies only if this guide specifically 

requires them. Submit the report written in the English language. Translate any text that appears in a language other than 

English into English in a complete and accurate manner. Keep a copy of the completed reports in your records.

We are making our reporting guides and other regulatory information available on the Internet under 

http://www.fda.gov/Radiation-EmittingProducts/. No copyright exists for these guides. Reproduce these guides as needed. 

If you would like to comment on the reporting guides, web site, or future electronic submissions, you may direct the comments 

to the address below. If you need additional regulations for electronic products or medical devices, you should contact the 

Division of Small Manufacturers, International and Consumer Assistance by telephone at 1-800-638-2041 or by facsimile at 

301-847-8149.

Sincerely yours,

Lillian J. Gill

Director

Office of Compliance

E-MAIL ADDRESS: dsmica@fda.hhs.gov

MAILING ADDRESS (see 21 CFR 1002.7 for further information):

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 

DOCUMENT MAIL CENTER – WO66-G609 

ATTN: ELECTRONIC PRODUCT REPORTS 

10903 NEW HAMPSHIRE AVENUE 

SILVER SPRING, MD 20993-0002

1 Manufacturer (see 21) CFR § 1000.3 (n)) means any person engaged in the business of manufacturing, assembling, or importing electronic products. 

2 Accidental Radiation Occurrences: 21 CFR 1002.20 requires manufacturers to immediately report accidental radiation occurrences (see 21 CFR 

1000.3(a) for the definition).

3 Notification: Title 21 CFR Part 1003 requires manufacturers to provide Notification of Defects or Failure to Comply. Send these notifications to the 

above address.

FORM FDA 3663 (06/23)
ABBREVIATED REPORTS FOR MICROWAVE PRODUCTS (OTHER THAN MICROWAVE OVENS)

General Information and use of this Guide

This guide for preparing abbreviated report for microwave products (other than microwave ovens) is issued by 

the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) for 

manufacturers and importers of radiation emitting electronic products. Manufacturers and importers of 

microwave products (see example of products listed below) are subject to the requirements promulgated under 

Chapter V, Subchapter C - Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act. 

Applicable radiation reporting regulations are contained in Title 21 CFR, Part 1002.12. Further information 

regarding the reporting requirements can be obtained by calling the Division of Small Manufacturers Assistance 

at 1-800-638-2041.

Retain this guide for photocopying (or formatting for word processing) for use in filing all reports in the future. 

When the report is received by CDRH, an acknowledgement letter will be sent to the submitter identifying an 

Accession Number. A unique accession number will be assigned for each MODEL FAMILY; all additional 

models within that family or changes to a previously reported model will be assigned the same accession 

number with a unique supplement number. Please reference the accession number when additional information 

is submitted.

There are some foreign manufacturers that do not have a firm or a representative in the United States working 

on their behalf. Part 1005.25 requires foreign manufacturers to assign a manufacturer's U.S. Agent to act on 

their behalf. The U.S. Agent may be an individual, a firm, a domestic corporation or an importer.

Summary of requirements: An Abbreviated report must be filed for each model or chassis. Any major changes 

made to the product design affecting the radiation emission, transmission or leakage will require sending a new

Abbreviated Report.

Mail Reports to: Electronic Product Reports 

Center for Devices and Radiological Health 

Document Mail Center – W066-G609 

10903 New Hampshire Avenue 

Silver Spring, MD 20993-0002

Examples of Microwave Products Covered By This Abbreviated Report: microwave heating or drying, 

microwave security system, RF sealers, electromagnetic induction and heating equipment, dialectric heaters 

(2-500 MHz), and other microwave power generating devices.

i

FORM FDA 3663 (06/23)
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FORM FDA 3663 (06/23)
ABBREVIATED REPORT FOR MICROWAVE PRODUCTS (OTHER THAN MICROWAVE OVENS)

A. PRODUCT IDENTIFICATION (CHECK APPROPRIATE BOX):

[ ] Microwave Heating (02)

Rf Sealers, Induction, 

Dielectric heaters (27)

[ ]

[ ] Microwave Diathermy (03)

[ ] Other (explain):

B. IDENTIFICATION OF FIRM:

B.1 Manufacturer Name:

Address:

Contact Official:

Title:

Signature:

Telephone:

Email address:

B.2 Importer or U.S. Agent Name:

Address:

Contact Official:

Title:

Signature:

Telephone:

Email address:

B.3 Factory Location(s):

B.4 Date of this Report:

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FORM FDA 3663 (06/23)
ABBREVIATED REPORT FOR MICROWAVE PRODUCTS (OTHER THAN MICROWAVE OVENS)

C. IDENTIFICATION OF MODEL(S) BEING REPORTED

Brand Model Number

D. APPLICATIONS - USES (Describe the intended and known uses or applications of each model):

E. OPERATIONAL CHARACTERISTICS (Provide a brief description of operational characteristics that affect 

radiation emissions, transmission, or leakage or that control exposure):

F. RADIATION LEVELS (Fill in the answers or check where indicated)

F.1 The maximum amount of radiation output allowed by your design is: .

F.2 The frequency of the output radiation is: .

F.3 The product operates [ ] continuously or [ ] has a duty cycle of .

F.4 Does the product produce modulation of the output radiation? [ ] Yes [ ] No

If yes, describe all types of modulation and how it is produced:

F.5 Does the product meets any know radiation standard? If yes, give the name of the performance or 

radiation standard:

F.5 Technical Information Attached - Attach technical information including the following: (a) operation and 

maintenance manual, (b) servicing manual, (c) performance or design data on the product, (d) wiring 

diagrams or schematics, and (e) appropriate warnings and labels with instruction to avoid unnecessary 

radiation exposure.

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FORM FDA 3663 (06/23)