FDA 3654 Standards Data Report for 510(k)s

Form Approved: OMB No. 0910-0120; Expiration Date: 1/31/2017

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
STANDARD TITLE

Special

Abbreviated

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], http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/Standards/default.htm

3

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

4

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

FORM FDA 3654 (4/14)

address of the test laboratory or certification body involved in conformance
assessment to this standard. The summary report includes information on
all standards utilized during the development of the device.
5

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
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm

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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

CONFORMANCE?

SECTION TITLE

Yes
TYPE OF DEVIATION OR OPTION SELECTED

No

N/A

❖

DESCRIPTION

JUSTIFICATION

SECTION NUMBER

CONFORMANCE?

SECTION TITLE

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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 1 hour per response, including the time to review
instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of
information. Send comments regarding this burden estimate or any other aspect of this information collection, including
suggestions for reducing this burden, to:
Department of Health and Human Services
"An agency may not conduct or sponsor, and
Food and Drug Administration
a person is not required to respond to, a
Office of Chief Information Officer
collection of information unless it displays a
Paperwork Reduction Act (PRA) Staff
currently valid OMB control number."
[email protected]
FORM FDA 3654 (4/14)

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