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Scott Colburn 

Director

Standards & Conformity Assessment Program

Office of the Center Director

Center for Devices and Radiological Health

Appropriate Use of Voluntary Consensus Standards 

in Premarket Submissions for Medical Devices
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• Final guidance

• Declaration of Conformity

• General Use

• FDA Review of Declaration of Conformity

• Supplementary Information versus Supporting 

Documentation 

• Questions and Answers

Agenda
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• Least burdensome approach

• Consistency about data requests and test reports

• Transparency about how horizontal standards are applied

• Reduce paperwork, Form 3654 in particular

Take Home Messages from Stakeholders
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Objectives

For any type of submission:

• Elect whether to provide a Declaration of Conformity or 

General Use

• What to provide if the submitter elects a Declaration of 

Conformity

• What to provide if the submitter elects General Use

• Determine when supporting documentation should 

accompany the Declaration of Conformity and when it 

should not.
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Appropriate Use of Voluntary Consensus Standards in 

Premarket Submissions for Medical Devices

Guidance
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2014: Draft Guidance 

Appropriate Use of Voluntary Consensus Standards in Premarket 

Submissions for Medical Devices

Scope:

• Describes use and documentation of FDA-recognized and non- recognized consensus standards for premarket submissions

• Discussed how FDA staff intends to rely on consensus 

standards during the review process. 

• Clarified and explained regulatory framework, policies, and 

practices

• Does not: 

– address the specific content required in any particular premarket 

submission. 

– consensus standards that are incorporated by reference 

(IBR) into regulation (e.g., hearing aid devices, professional 

and patient labeling, 21 CFR 801.420(c)(4)). 

– For additional information, see the Standards Incorporated by

Reference Database.
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Comments Fell Into Four Categories

• The two policy changes related to the non-acceptance of 

Declaration of Conformity & promissory statements

• Deviations

• Form 3654

• Transition periods 

Comments on the Draft
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• Incorporation of changes to Section 514(c) amended by 21st Century Cures Act

• Clarification of Section 514(c) about when deviations are made and the use of 

promissory statements

• Clarification of the use of standards with or without a Declaration of Conformity

• Adoption of ISO/IEC 17050-1 Conformity assessment – Supplier’s declaration of 

conformity

• Adoption of ISO/IEC 17050-2 Conformity assessment – Supplier’s declaration of 

conformity – Supporting documentation

– Clarification of when and how much supporting information should be provided

• Inclusion of a transition period for all standards that are withdrawn and replaced 

with a newer version 

• Form 3654 no longer needed

2018 Final Guidance: Changes from Draft to Final
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21st Century Cures Act

1. Clarified outside requests for recognition

2. Added:

• 60-day timeframe

• Basis for recognition, all or part

• Basis for non-recognition

• Training for all reviewers of premarket submissions

• Periodic training on standards
Declaration of Conformity (DOC)

What is a Declaration of Conformity?

–Attestation that the device is in conformity

–If submitter declares conformity, a Declaration of Conformity must be 

included in the submission

–Reduces the amount of supporting data and information submitted to 

FDA
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Declaration of Conformity (DOC)

What does this mean?

–All normative requirements of the standard are met and testing 

conducted before premarket submission

–Testing is on the finished device or final finished device
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What is a Finished Device

Under 21 CFR 820.3(l), A 

Finished Device is:

“Any device or accessory to any 

device that is suitable for use or 

capable of functioning, whether 

or not it is packaged, labeled, or 

sterilized.” 

A Final Finished Device is:

Any device that includes all 

manufacturing processes for the 

“to be marketed” device, 

including packaging and 

sterilization, if applicable. 
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1. Name and address of applicant/sponsor

2. Product/device identification

3. Statement of conformity (not compliance)

4. List of standards applicable including options selected

5. FDA recognition number for each standard

6. Date and place of issuance of the Declaration of 

Conformity

7. Signature, printed name

8. Any limitation on the Declaration of Conformity 

ISO/IEC 17050-1 Declaration of Conformity 

(DOC) Elements
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Example of a Declaration of Conformity

Declaration of Conformity to Recognized Standards

I certify that, in my capacity as CEO of XYZ, Inc., that the subject of this Traditional 510(k), the ABC Monitor, 

conforms with the following FDA-recognized standards:

• [Rec. Number 19-4] ANSI/AAMI ES60601-1 Medical electrical equipment – Part 1: General requirements for 

safety and essential performance, 

• [Rec. Number 19-1] ANSI/AAMI IEC 60601-1-2 Medical electrical equipment – Part 1-2 General 

requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests

• [Rec. Number 12-293] IEC 60601-2-37 Medical electrical equipment – Part 2-37: Particular requirements for 

the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

All requirements were met, alternative series of tests were not performed, all requirements were applicable to 

the device, no deviations from each applicable standard were applied, and there were no differences between 

the tested device and the device to be marketed.

All tests were performed by [insert Testing Lab, and address if applicable]. 

Signed: Jane Smith Date: October 25, 2018 Address: Medical Device Road,

CEO, XYZ, Inc. Minneapolis, MN
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Alternate Example of a Declaration of Conformity

Declaration of Conformity to Recognized Standards

I certify that, in my capacity as CEO of XYZ, Inc., that the subject of this Traditional 510(k), the ABC Monitor, 

conforms with the following FDA-recognized standard:

[Rec. Number 12-293] IEC 60601-2-37 Medical electrical equipment – Part 2-37: Particular 

requirements for the basic safety and essential performance of ultrasonic medical 

diagnostic and monitoring equipment

All normative requirements were met, alternative series of tests were not performed, all requirements were 

applicable to the device, no deviations from the standard were applied, and there were no differences between the 

tested device and the device to be marketed.

All tests were performed by [insert Testing Lab, and address if applicable]. 

Signed: Jane Smith Date: October 25, 2018 Address: Medical Device Road,

CEO, XYZ, Inc. Minneapolis, MN
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Why are normative references used in standards?

– Saves time

– Saves resources

– Promotes harmonization & uniformity

Normative References
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What do we mean by a normative reference in a consensus standard?

– Bibliography (Informative)

– Normative References (Essential for understanding how to apply 

the standard. 

Normative References
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How do the requirements of a normative reference get incorporated?

–Referenced within the body of the text

–In its own section (Clause 2 if ISO)

Normative References
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Do all the requirements apply and does the Declaration of Conformity 

have to include them all?

–Usually limited to a specific clause or clauses

Normative References
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Does FDA recognition mean that all the normative requirements are 

automatically recognized?

– Only to the extent that they are used within the recognized 

standard

–Not automatically recognized independently

Normative References
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ISO/IEC 17050-2

ISO/IEC 17050-2 Conformity assessment – Part 2: Supplier’s declaration of 

conformity – Supporting documentation

• Description of the object of the test

• Conformity assessment results including:

– Description of the test method

– If Good Laboratory Practices (GLPs) or Quality Systems Regulations 

(QSRs) were followed

– Results

–Assessment of the results including: choices, selections, adaptations, 

modifications or concessions made
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Supplementary Information Sheet 

versus 

Supporting Documentation 

Supplementary Information 

Sheet

• CDRH’s determination of how the 

FDA-recognized standard may be 

used to satisfy a portion of the 

FD&C act

• Example: Describes a complete 

recognition or sections that are 

excluded from FDA’s recognition

Supporting Documentation

• Describes how the medical device 

conforms to the FDA-recognized 

standard

• Example: Describes acceptance 

criteria to demonstrate essential 

performance of a medical device

≠
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Supporting Documentation

Supporting documentation accompanies a Declaration of Conformity when:

• The standard describes a test method or procedure with NO acceptance 

criteria

• The standard includes acceptance criteria but NO test method

• The standard includes choices:

–What is tested

–How it is tested (method)

–Describes a process, for example, risk assessment 
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Supporting Documentation

Supporting documentation does NOT accompany a Declaration of 

Conformity when:

• The FDA-recognized standard includes both a test method and 

acceptance criteria

• Or, there is more than one standard, for example, one a test method 

and one with acceptance criteria

• The FDA-recognized standard is a design standard
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FDA’s Declaration of Conformity Review

• ISO/IEC 17050-1 elements or equivalent

• Standard is FDA-recognized

• No deviations made to normative requirements

• Standard is applicable to the device subject of the submission

• Supporting documentation, if necessary, per ISO 17050-2 or 

equivalent

• Data and information are in conformance with normative requirements 

• Declaration of Conformity does not include a promissory statement
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Why can FDA rely on a Declaration of Conformity?

• Section 301(x) of the FD&C Act

• Section 501(e)(2) of the FD&C Act

• Section 301(q)(2) of the FD&C Act

• 21 CFR Part 58 Good Laboratory Practices (GLPs)

• 21 CFR Part 820 Quality System Regulations (QSRs)

–Design validation, 21 CFR 820.30(g)

–Process validation, 21 CFR 820.75(b)

• Laboratory accreditation

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Complete Test Reports Requested When

• A Declaration of Conformity is not provided

• Standard has neither a test method, nor predefined acceptance 

criteria

• Deviations to the normative requirements of the standard have 

been made
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FDA Review of Declaration of Conformity 

and Supporting Documentation 

Type of Consensus Standard for which a DOC might be 

provided

Should submission 

include test report?

Should submission include 

supplemental documentation 

per ISO/IEC 17050-2?

Design Standard No No

Standard Includes:

Test method or procedure 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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General Use of Consensus Standard

• No Declaration of Conformity elected

• Deviations

• Device was modified (adapted)

• Standard not recognized

• Submitter used an older version no longer recognized
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When Standards Change

Before Review During Review After Review

Guidance encourages presubmission (“Q-sub”)interactionsFDA will continue to review 

based on the previously 

recognized version

Changes to standards are not 

retroactive

Submitter’s should provide a 

strategy that addresses the 

differences between the older 

and the current version

If the new revision addresses 

new safety or effectiveness issue 

that is relevant to the final 

decision, FDA may ask the 

submitter to either meet the 

new requirement, or provide 

alternative data/information 

with a rationale.

Do not affect the status of 

clearance or approval

Superseded standards that FDA 

has withdrawn may not be used 

with a Declaration of Conformity

Focus is on issues that affect 

safety and/or effectiveness

If the Submitter received 

clearance based on a Declaration 

of Conformity, but the standard 

is withdrawn, the device remains 

legally marketed.
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• Standards that have been withdrawn and replaced

• Specified amount of time

• Located in the Supplemental Information Sheet (SIS) below the extent of recognition

• Standards that impact Quality Systems Regulations or other horizontal processes will 

receive a 2-3 year transition

• Will consider ISO/IEC implementation/withdrawal dates

Why?

• Allows the submitter to continue to test and develop without additional retesting

• Allows time to revalidate processes under 21 CFR 820.75(b)

• Allows testing laboratories time to validate new test methods

Transition Periods
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Promissory Notes

• A statement in which the submitter indicates that the device is not yet 

known to be in conformance, but will conform before marketing

• Used in certain, limited situations. For example, installation 

requirements, expiration dating, chronic or long-term testing, postmarket testing.

• Not appropriate for a Declaration of Conformity
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• FDA will periodically update the Recognized Standards Database for 

which recognition is pending

• FDA will follow-up pending recognitions with a Federal Register 

Notice

• Includes a Recognition Number

• Includes a Supplemental Information Sheet

Pending Recognitions
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Resources

National Institute of Standards and Technology: www.nist.gov/standardsgov/index.cfm

Standards and Conformity Assessment Program: 

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm#intro

FDA Recognized Consensus Standards Database: 

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

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: 

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.p

df

Device Advice: Comprehensive Regulatory Assistance: 

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

CDRH Learn: https://www.fda.gov/training/cdrhlearn/default.htm

FDA SMG 9100.1: www.fda.gov/aboutfda/reportsmanualsforms/staffmanualguides/ucm193332.htm
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Questions?

Division of Industry and Consumer 

Education: DICE@fda.hhs.gov

Slide Presentation, Transcript and 

Webinar Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: 

How to Study and Market Your Device, 

in the section called Standards