FDA 3645 Therapy Ultrasound Annual Report

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

FORM FDA 3645 (6/15)
Guide for Preparing Annual Reports for
Ultrasonic Therapy Products

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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paper 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 guide may be sent to the above
address or may be discussed by calling 1-800-638-2041.

FORM FDA 3645 (6/15)

GUIDE FOR PREPARING ANNUAL REPORTS FOR
ULTRASONIC THERAPY PRODUCTS

SEPTEMBER 1996

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

FORM FDA 3645 (6/15)

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: [email protected]
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 3645 (6/15)

INSTRUCTIONS
General
You need to submit only the completed forms and any information you have provided on
separate sheets. If you use separate sheets or additional copies of the forms, label each page with
sequential lettering (example: Page 3a, Page 3b, Page 3c).
The forms provide blanks to be filled in, boxes [ ] to be checked, and tables or graphs to be
completed, They may be prepared with a typewriter or hand-printed in black ink.
1. Identification of Manufacturer
Fill in the requested information and sign where indicated. Fill in the years in the reporting
period (example: The report due on September 1, 1983, should cover the reporting year July 1,
1982, through June 30, 1983)
2. Production Status
Check the statement that applies to your firm and take the indicated action.
3. Current Production Tabulation
Provide production data, using the form or a comparable tabulation. If additional space is needed,
use another copy of the form or attach a separate sheet and label it Part 3.
Accession No.:

For previously reported models, CDRH will have assigned this number
and reported it to you.

Brand:

Provide the brand name of the product, if different than manufacturer's
name. On a separate sheet, provide the complete address for each
importer or distributor of each brand. Label the sheet Part 3.

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.

4. 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 previous product reports should
be reviewed and updated. Compare your current procedures with those submitted in your
previous product reports. Check the appropriate answers and take any indicated action.

FORM FDA 3645 (6/15)

5. Summary of Test Results
You are required by 21 CFR 1002.30(a) (2) to maintain results of quality control tests. For each
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
1050.10).
5.1 Results of Production Tests
Check the appropriate answers and fill in the requested data.
5.2 Results of Audit Tests
Fill in the requested data.
6. Correspondence Concerning Radiation Safety
You are required by 21 CFR 1002.30(a) (4) to maintain copies of communications 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.
7. 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.
Fill in the information on the location of records storage and check the means of tracing
products.

FORM FDA 3645 (6/15)

ULTRASOUND THERAPY ANNUAL REPORT (24)

1. Identification of Manufacturer
Report Date:
Company Name:
Address:

Email address:
This Annual Report is submitted in accordance with 21 CFR 1002.11 for the period July 1, 19
through June 30,
Corresponding Official:
Name:
Title:
Telephone number:
Email address:
Signature:

2. Production Status
[ ] Products were manufactured during this period and the firm is still in business. If you check this,
submit this entire report.
[ ] No products were manufactured during this period but the firm is still in business, and expects to
manufacture in the future. If you check this, submit Part 6 of this report.
[ ] No products were manufactured during this period and the firm is now out of business. If you
check this, submit Part 6 of this report.

[ ] Products were manufactured during this period but the firm is now out of business. If you check
this, submit this entire report.

FORM FDA 3645 (6/15)

3. Current Production Tabulation
Accession
Number

Brand
Designator

Generator
Model
Number

Number of
units
produced

Introduced
into
commerce
(mo/yr)

Discontinued
(mo/yr)

4. Procedures for Quality Control and Testing
When, and by whom, were the written procedures for assessing and controlling radiation safety last
reviewed? (These include prototype testing, incoming materials testing, assembly testing, retesting after
repair, and service testing.)

For each model family currently in production, are reports provided to CDRH, and are the procedures
contained in them up-to-date, complete, and accurate?

If you answered NO, provide the current procedures in a supplement to the appropriate product report.

5. Summary of Test Results
5.1 Results of Production Tests
What percentage of production units were tested for accuracy of indicated power?

Tests were performed at the following indicated power settings with the maximum measured error as
indicated at each setting:

FORM FDA 3645 (6/15)

watts

% error

watts

% error

watts

% error

watts

% error

How many generators were outside the test specifications and required corrective action(s)?
Are all records of power calibrations reviewed by management prior to product release?
Have the measuring instruments used in the testing been modified, repaired or recalibrated within the
last year?
If yes, explain the circumstances surrounding the modification, repair or recalibration:

5.2 Results of Audit Tests
Beam Nonuniformity Ratio (BNR)
How many BNR measurements were made?
What percentage of applicator model production had BNR measurements made?
What was the mean BNR?
What was the standard deviation?
What is the claimed maximum BNR?

Effective Radiating Area (ERA)
How many ERA measurements were made?
What percentage of applicator model production had ERA measurements made?
What was the mean ERA?
What was the standard deviation?
What is the claimed ERA?
What are maximum and minimum ERA values allowable?
Maximum
FORM FDA 3645 (6/15)

Minimum

6. Correspondence Concerning Radiation Safety
How many letters were received from users, dealers, or others about possible radiation exposure during
use of the product?
Attach a copy of each letter.
How many letters were received from dealers, distributors, or others concerning the need for repair,
adjustment, or replacement of a part to maintain radiation safety of the product?
Attach a summary of correspondence or a sample. Identify any trends in failed components or
adjustments needed during servicing.
How many notices or brochures were sent to users, dealers, or service personnel on precautions or actions
to be taken to maintain the radiation safety of the product?
Attach a sample of any correspondence.
7. Distribution Records
Where are production facility shipping records and dealer records (when returned) maintained?

Products can be traced from these records by:
[

] Model

[

] Serial Number

[

] Date of manufacture

[

] Other (specify)

FORM FDA 3645 (6/15)