FDA 3654 Standards Data Report for 510(k)s

Form Approved: OMB No. 0910-0120; Expiration Date: 12/31/13

Department of Health and Human Services
Food and Drug Administration

STANDARDS DATA REPORT FOR 510(k)s
(To be filled in by applicant)

This report and the Summary Report Table are to be completed by the applicant when submitting a 510(k) that references a national or international standard. A separate report is required for each standard referenced in the 510(k).
TYPE OF 510(K) SUBMISSION
Traditional

Special

Abbreviated

STANDARD TITLE 1

Yes

Please answer the following questions

No

Is this standard recognized by FDA 2 ? ..................................................................................................
FDA Recognition number 3 .................................................................................................................... #
Was a third party laboratory responsible for testing conformity of the device to this standard identified
in the 510(k)? ........................................................................................................................................
Is a summary report 4 describing the extent of conformance of the standard used included in the
510(k)? ..................................................................................................................................................
If no, complete a summary report table.
Does the test data for this device demonstrate conformity to the requirements of this standard as it
pertains to this device? ..........................................................................................................................
Does this standard include acceptance criteria? ...................................................................................
If no, include the results of testing in the 510(k).
Does this standard include more than one option or selection of tests? ................................................
If yes, report options selected in the summary report table.
Were there any deviations or adaptations made in the use of the standard?.........................................
If yes, were deviations in accordance with the FDA supplemental information sheet (SIS) 5 ? .............
Were deviations or adaptations made beyond what is specified in the FDA SIS?.................................
If yes, report these deviations or adaptations in the summary report table.
Were there any exclusions from the standard? .....................................................................................
If yes, report these exclusions in the summary report table.
Is there an FDA guidance 6 that is associated with this standard?.........................................................
If yes, was the guidance document followed in preparation of this 510k? .............................................
Title of guidance:
1

The formatting convention for the title is: [SDO] [numeric identifier]
[title of standard] [date of publication]

2

Authority [21 U.S.C. 360d], www.fda.gov/cdrh/stdsprog.html
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/
search.cfm

5

The summary report should include: any adaptations used to adapt to
the device under review (for example, alternative test methods);
choices made when options or a selection of methods are described;
deviations from the standard; requirements not applicable to the
device; and the name and address of the test laboratory or

The supplemental information sheet (SIS) is additional information
which is necessary before FDA recognizes the standard. Found at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/
search.cfm

6

The online search for CDRH Guidance Documents can be found at
www.fda.gov/cdrh/guidance.html

3

4

FORM FDA 3654 (12/10)

certification body involved in conformance assessment to this
standard. The summary report includes information on all standards
utilized during the development of the device.

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PSC Graphics (301) 443-6740

EF

EXTENT OF STANDARD CONFORMANCE
SUMMARY REPORT TABLE
STANDARD TITLE

CONFORMANCE WITH STANDARD SECTIONS*
SECTION NUMBER

SECTION TITLE

CONFORMANCE?
Yes

TYPE OF DEVIATION OR OPTION SELECTED

No

N/A

❖

DESCRIPTION

JUSTIFICATION

SECTION NUMBER

SECTION TITLE

CONFORMANCE?
Yes

TYPE OF DEVIATION OR OPTION SELECTED

No

N/A

❖

DESCRIPTION

JUSTIFICATION

SECTION NUMBER

SECTION TITLE

CONFORMANCE?
Yes

TYPE OF DEVIATION OR OPTION SELECTED

No

N/A

❖

DESCRIPTION

JUSTIFICATION

* For completeness list all sections of the standard and indicate whether conformance is met. If a section is not applicable (N/A) an
explanation is needed under “justification.” Some standards include options, so similar to deviations, the option chosen needs to be
described and adequately justified as appropriate for the subject device. Explanation of all deviations or description of options
selected when following a standard is required under “type of deviation or option selected,” “description” and “justification” on the
report. More than one page may be necessary.
❖

Types of deviations can include an exclusion of a section in the standard, a deviation brought out by the FDA supplemental
information sheet (SIS), a deviation to adapt the standard to the device, or any adaptation of a section.

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 1 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
1350 Piccard Drive, Room 400
Rockville, MD 20850
FORM FDA 3654 (12/10)

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.
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