At the heart of medical device innovation and safety is the meticulous process of regulatory compliance, a crucial step of which is the completion of the Standards Data Report for 510(k)s. Mandated by the Department of Health and Human Services and overseen by the Food and Drug Administration (FDA), this report demands careful documentation from applicants intending to demonstrate that their devices meet established national or international standards. Each report, unique to a specific standard referenced in a 510(k) submission, elucidates whether a device conforms to FDA-recognized standards, detailing testing outcomes, any deviations or adaptations to standard protocols, and justifications thereof. This process not only ensures the safety and efficacy of medical devices but also aligns with the FDA's mission to safeguard public health. Moreover, it provides a structured pathway for applicants navigating through the complex terrain of device approval, encouraging transparency and rigor from the initial submission through to market entry. Inherent to the report are questions regarding third-party laboratory involvement, inclusion of a summary report table describing the extent of conformance, and adherence to any associated FDA guidance, all of which must be meticulously answered to facilitate the FDA's review. The construction of this document underscores the essential collaboration between the medical device industry and regulatory bodies, striving collectively to uphold high standards of healthcare innovation and patient safety.
| Question | Answer |
|---|---|
| Form Name | Form Standards |
| Form Length | 2 pages |
| Fillable? | No |
| Fillable fields | 0 |
| Avg. time to fill out | 30 sec |
| Other names | form standards pdf, fda 3654, form 3654, fda data report |
Form Approved: OMB No.
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 refer- ences a national or international standard. A separate report is required for each standard referenced in the 510(k).
TYPE OF 510(K) SUBMISSION |
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Traditional |
Special |
Abbreviated |
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STANDARD TITLE 1 |
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Please answer the following questions |
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Yes |
No |
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Is this standard recognized by FDA 2 ? |
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FDA Recognition number 3 |
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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:
1The formatting convention for the title is: [SDO] [numeric identifier] [title of standard] [date of publication]
2Authority [21 U.S.C. 360d], http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Standards/default.htm
3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
4The 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 certification body involved in conformance assessment to this standard. The summary report includes information on all standards utilized during the development of the device.
5The 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
6The online search for CDRH Guidance Documents can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/default.htm
FORM FDA 3654 (4/14) |
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PSC Publishing Services (301)
EXTENT OF STANDARD CONFORMANCE
SUMMARY REPORT TABLE
STANDARD TITLE
CONFORMANCE WITH STANDARD SECTIONS*
SECTION NUMBER |
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SECTION TITLE |
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TYPE OF DEVIATION OR OPTION SELECTED |
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DESCRIPTION |
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JUSTIFICATION |
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SECTION TITLE |
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TYPE OF DEVIATION OR OPTION SELECTED |
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DESCRIPTION |
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JUSTIFICATION |
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SECTION NUMBER |
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SECTION TITLE |
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TYPE OF DEVIATION OR OPTION SELECTED |
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DESCRIPTION |
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JUSTIFICATION |
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CONFORMANCE? |
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Yes |
No |
N/A |
CONFORMANCE?
Yes No N/A
CONFORMANCE? |
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Yes |
No |
N/A |
*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 |
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Food and Drug Administration |
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a person is not required to respond to, a |
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Office of Chief Information Officer |
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collection of information unless it displays a |
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Paperwork Reduction Act (PRA) Staff |
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currently valid OMB control number." |
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PRAStaff@fda.hhs.gov |
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FORM FDA 3654 (4/14) |
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