3654 Standard Data Report for 519 (K)s

Form Approved: OMB No. 0910-0120; Expiration Date: xx/xx/xx

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 is 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

Please answer the following questions

Yes

No

Is this standard recognized by FDA 2 ? ..................................................................................................
FDA Recognition number

3

OF
O
PR

................................................................................................................... #

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)? ..................................................................................................................................................
Does the test data for this device demonstrate conformity to the requirements of this standard as it
pertains to this device? .........................................................................................................................
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, complete a summary report table.
Were there any exclusions from the standard? .....................................................................................
If yes, complete a summary report table.
Was a FDA guidance 6 document used in the preparation of this 510(k)? .............................................
Guidance Title:
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

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); deviations from the standard; requirements not
applicable to the device; and the name and address of the test

FORM FDA 3654 (10/06)

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 of CDRH Guidance Documents can be found
at www.fda.gov/cdrh/guidance.html

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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

No

N/A

❖

DESCRIPTION

JUSTIFICATION

SECTION NUMBER

SECTION TITLE

CONFORMANCE?
Yes

TYPE OF DEVIATION

No

N/A

❖

OF
O
PR

DESCRIPTION

JUSTIFICATION

SECTION NUMBER

SECTION TITLE

CONFORMANCE?
Yes

TYPE OF DEVIATION

No

❖

DESCRIPTION

JUSTIFICATION

* For completeness list all sections of the standard and indicate whether conformance is met. Explanation of all deviations is
required under “type of deviation”, “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), or an adaptation in the 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:
Center for Devices and Radiological Health
1350 Piccard Drive
Rockville, MD 20850
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.

FORM FDA 3654 (10/06)

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N/A