How to Use Consensus Standards in 

Premarket Submissions 

Scott Colburn, CAPT, USPHS 

Director 

CDRH Standards and Conformity Assessment Program 

Office of Strategic Partnerships and Technology Innovation 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration 
Value of Consensus Standards

Science-based least burdensome regulatory approach

Enhance 

regulatory 

science 

Promote 

quality 

 Improve 

patient 

access 

2
Learning Objectives

• Explain how to use standards in device submissions 

• Describe how declarations of conformity (DOC) 

improve device review 

• Identify when you need supplemental documentation 

• Discuss Helpful Tips for using standards and DOCs in 

submissions

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How to Use Consensus Standards in 

Device Submissions

4
Use of Consensus Standards

• Voluntary 

• Only mandatory if cited in regulation 

− Example: 21 CFR 801 cites ASTM D3492 

• In any type of submission 

• With a DOC (recognized standards only), “General Use” (any 

standards, recognized or not) or both

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How to Cite Standards-Cover Sheet

Form FDA 3514 Cover 

Sheet* Section J 

• Examples Section 

• Entries for Utilization 

of Standards

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* Download Form FDA 3514 “CDRH Premarket 

Review Submission Cover Sheet” at: 

www.fda.gov/media/72421/download
How to Cite Standards-Cover Sheet

Entries for Utilization of Standards 

Add Row/Standard

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How to Cite Standards-Cover Sheet

Form 3514 Cover Sheet 

Section J: 

Recognition Number 

Recognized Consensus Standards database 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 8
How to Cite Standards-Cover Sheet

Form 3514 Cover Sheet 

Section J: 

Declaration of Conformity 

or General Use

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How to Cite Standards-Cover Sheet

Form 3514 Cover Sheet 

Section J: 

Standard

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How to Cite Standards-Cover Sheet

Form 3514 Cover Sheet 

Section J: 

Location 

(In Submission)

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Declaration of Conformity 

(DOC)

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What is a DOC? 

• Attestation that device conforms with cited FDA - recognized 

standard 

– All normative requirements are met 

– All testing has been conducted 

– Testing is on finished device or final finished device 

• If submitter declares conformity with a recognized standard, a 

DOC accompanies the submission 

→ Use of DOC with a recognized standard generally reduces 

documentation needed in a submission 

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Elements of a DOC

• Name and address of applicant/sponsor responsible for DOC 

• Product/device identification 

• Statement of conformity 

• List of standards to which DOC applies 

• FDA recognition number for each standard

Please see ISO/IEC 17050-1:2004(en): Conformity assessment - supplier's declaration of conformity - Part 1: General 

requirements and FDA’s guidance: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 

for Medical Devices

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Elements of a DOC, cont’d

• Date and place of issuance of DOC 

• Signature, printed name, and function of applicant/sponsor 

responsible for DOC 

• Any limitation on validity of DOC (e.g., how long declaration is 

valid, what was tested, or concessions made about testing 

outcomes) 

• Supplemental documentation per ISO 17050 - 2 or equivalent 

Please see ISO/IEC 17050-1:2004(en): Conformity assessment - supplier's declaration of conformity - Part 1: General 

requirements and FDA’s guidance: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 

Medical Devices 15
Elements of a DOC

• Responsible Party 

• Product/Device Identification 

• Statement of Conformity 

• Limitations on Validity of DOC 

• Signature

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Responsible Party and 

Product/Device Identification

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Statement of Conformity

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Limitations on Validity of DOC 

and Signature

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“General Use” of Standards

• May cite any consensus standard 

• Should include complete test reports 

• Considerations: 

– If modifications not referenced or permitted in 

standard, should include complete test reports 

– When in doubt, ask FDA review team!

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Supplemental Documentation

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Supplemental Documentation

Standard Type Complete Test

Report Needed?

Supplemental Documentation 

Needed (ISO/IEC 17050-2 )?

Design No No

Test Method Acceptance 

Criteria

Included Not Included No Yes, Criteria/Summary Results

Not Included Included No Yes

Included Included No No

Not Included Not included Yes Complete Test Report

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Supplemental Documentation

Standard Type Complete Test Report 

Needed?

Supplemental Documentation 

Needed (ISO/IEC 17050-2 )?

Design No No

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Supplemental Documentation

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Test Method Acceptance 

Criteria

Complete Test Report 

Needed?

Supplemental Documentation 

Needed (ISO/IEC 17050 - 2 )?

Included Not Included No Yes, Criteria/Summary Results

Not Included Included No Yes

Included Included No No

Not Included Not included Yes Complete Test Report
Supplemental Documentation

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Test Method Acceptance 

Criteria

Complete Test Report 

Needed?

Supplemental Documentation 

Needed (ISO/IEC 17050-2 )?

Included Not Included No Yes, Criteria/Summary Results

Not Included Included No Yes

Included Included No No

Not Included Not included Yes Complete Test Report
Supplemental Documentation

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Test Method Acceptance 

Criteria

Complete Test Report 

Needed?

Supplemental Documentation 

Needed (ISO/IEC 17050-2 )?

Included Not Included No Yes, Criteria/Summary Results

Not Included Included No Yes

Included Included No No

Not Included Not included Yes Complete Test Report
Supplemental Documentation

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Test Method Acceptance 

Criteria

Complete Test Report 

Needed?

Supplemental Documentation 

Needed (ISO/IEC 17050-2 )?

Included Not Included No Yes, Criteria/Summary Results

Not Included Included No Yes

Included Included No No

Not Included Not included Yes Complete Test Report
Supplemental Documentation

• Supplemental documentation is needed when: 

– Standard has neither test method nor prespecified acceptance 

criteria 

– Deviations or adaptations have been made to recognized standard 

• Provide complete test report as supplemental 

documentation 

• Note: If elect “General Use”, additional documentation may 

be needed

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ANSI/AAMI HE75:2009(R)28 

Not FDA - recognized: Section 9: Usability testing FDA Human Factors Guidance

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Section Contents

1 Conclusion

2 Descriptions of intended device users, 

uses, use environments, and training

3 Description of device user interface

4 Summary of known use problems

5 Analysis of hazards and risks 

associated with use of device

6 Summary of preliminary analyses and 

evaluations

7 Description of categorization of critical 

tasks

8 Details of human factors validation 

testing

FDA Guidance: Applying Human Factors & 

Usability Engineering to Medical Devices 
When Supplemental Documentation 

is NOT Needed

• Design standard is cited 

• Standard includes both: 

– test method and 

– pre-specified performance limit

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Helpful Tips for Using Standards 

in a Submission

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What to Avoid

• Inappropriate use of consensus standards 

– Not applicable to your device or intended use 

– Not knowing Extent of Recognition (complete or partial) 

• Inappropriate use of a declaration of conformity 

– Citing non - recognized standards (such as older, previous versions) 

– Deviations from recognized standards 

– Using DOCs without appropriate supplemental documentation

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What to Avoid

• Assuming that use of consensus standards satisfies 

ALL submission questions 

• Not checking relevant regulation/guidance for 

additional requirements 

• FDA Form 3654: Standards Data Report for 510(k)s; 

no longer available!

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Summary

• How to use standards in device submissions 

• How DOCs improve device review 

• Use of supplemental documentation 

• Helpful tips for using standards and DOCs in 

submissions

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Resources

• Standards & Conformity Assessment Program (S - CAP) 

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/

• FDA Recognized Consensus Standards Database 

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

• Device Advice: Comprehensive Regulatory Assistance 

www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

• CDRH Learn: How to Study and Market Your Device: Standards

www.fda.gov/training-and-continuing-education/cdrh-learn#collapseTwo

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Guidances

• Appropriate Use of Voluntary Consensus Standards in Premarket 

Submission for Medial Devices 

www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-usevoluntary-consensus-standards-premarket-submissions-medical-devices

• Recognition and Withdrawal of Voluntary Consensus Standards 

www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-andwithdrawal-voluntary-consensus-standards

Contact: CDRHStandardsStaff@fda.hhs.gov

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Industry Education: 

Three Resources for You

1. CDRH Learn: Multi - Media Industry Education 

§ Over 200 modules 

§ Videos, audio recordings, power point presentations, software - based “how to” modules 

§ Mobile - friendly: access CDRH Learn on your portable devices 

www.fda.gov/CDRHLearn

2. Device Advice: Text - Based Education 

§ Comprehensive regulatory information on premarket and postmarket topics 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE) 

§ Contact DICE if you have a question 

§ Email: DICE@fda.hhs.gov 

§ Phone: 1(800) 638 - 2041 or (301) 796 - 7100 (Hours: 9 am - 12:30 pm; 1 pm - 4:30pm EST) 

§ Web: www.fda.gov/DICE

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Your Call to Action

• Put standards to work 

– Use FDA - recognized standards in your submissions 

• Make sure your documentation is complete 

– Know when you need DOCs and supplement 

documentation 

• Participate in standards development!

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