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Form Approved: OMB No. 0910-0120; Expiration Date: 8/31/10

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 1 Special Abbreviated

Please answer the following questions
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 guidance6 that is associated with this standard? ......................................................... If yes, was the guidance document followed in preparation of this 510k? ............................................. Title of guidance:
1

Yes

No

The formatting convention for the title is: [SDO] [numeric identifier] [title of standard] [date of publication] Authority [21 U.S.C. 360d], www.fda.gov/cdrh/stdsprog.html http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/ search.cfm 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
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2 3

certification body involved in conformance assessment to this standard. The summary report includes information on all standards utilized during the development of the device. 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 The online search for CDRH Guidance Documents can be found at www.fda.gov/cdrh/guidance.html

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6

FORM FDA 3654 (9/07)

Page 1

PSC Graphics (301) 443-1090

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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

SECTION TITLE

CONFORMANCE? Yes No N/A

TYPE OF DEVIATION OR OPTION SELECTED



DESCRIPTION

JUSTIFICATION

SECTION NUMBER

SECTION TITLE

CONFORMANCE? Yes No N/A

TYPE OF DEVIATION OR OPTION SELECTED



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: 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 (9/07) Page 2