Standards: Resources and

Use in Premarket Submissions

Jianchao Zeng

Senior Standards Advisor, Standards Management Staff

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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Learning Objectives

• Locate FDA-recognized standards

• Find FDA guidances on the use of standards

• Identify and decipher a standards title

• Locate standards Supplementary Information Sheet (SIS)

• Discuss the two main ways to use standards

• Describe the elements of a Declaration of Conformity (DoC) and 

how it’s used
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Not all Standards are the Same

• Each standard developing organization (SDO) produces different 

types of standards

– e.g., objective performance criteria, guidelines, practices

• Knowing the type of standard will guide the information needed 

in a submission 
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FDA Recognized Consensus

Standards Database

• Repository for recognized standards

• Publicly available at: 

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

• Supplementary Information Sheet (SIS)

– provided for each recognized standard

– identifies the device types addressed by the standard

• May be used with or without a Declaration of Conformity
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Consensus Standards Database
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Search Capabilities

• Standards Organization

• Standard Designation 

Number 

• Standards Title or Keywords

• Specialty Task Group Area

• Product Classification/ 

Product Code

• Regulation Number

• Type of Standard

• FR List Publication Date

• Sort Feature
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Sample Search: Cardiovascular
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SIS

• CDRH’s determination of how a standard should be used 

in a premarket submission or other Center process

• Built-in latitude to support a standard, even if some 

aspect conflicts with Agency position

• Standard may still be useful to the rest of the world even 

if not directly useful in review (practice guidelines)
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Information on a SIS

• Recognition List Number and FR 

Publication Date

• Recognition Number, Designation 

and Title

• Date of the Standard

• Parallel Adoptions (if any) 

• Scope

• Rationale for Recognition 

• Extent of Recognition

• Transition (if implemented)

• Related CFR Citations and Product 

Codes 

• Relevant Guidance(s)

• FDA Technical Contact(s)

• SDO Address

• History of Recognition
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International Standards Title
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National Standards Title
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U.S. Parallel Adoption
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Standards Guidances

• Recognition and Use of Consensus Standards

• Use of Standards in Substantial Equivalence 

Determinations

• Frequently Asked Questions on Recognition of 

Consensus Standards
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Two Ways to Use a Standard 

in Submissions

1. General Use

2. Declaration of Conformity
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General Use

• When standards are used/cited without a declaration 

of conformity

• Applies to any standard whether or not it is 

recognized

• Supported by submission of a full test report

• May use for any type of submission

– e.g., 510(k), PMA, HDE, IDE, De Novo
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Declaration of Conformity (DoC) 

• Submitter certifies that device conforms to applicable 

requirements of FDA-recognized consensus standards

• Not applicable:

– deviates from FDA-recognized standard 

– standard not recognized by FDA
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Elements of a DoC 

• Name and Address 

• Product/device identification

• Statement of Conformity

• List of Standards and FDA recognition number
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Elements of a DoC 

• Date and Place of Issuance

• Signature, printed name of responsible person

• Any limitation of the Declaration of Conformity

See: ISO 17050-1 Conformity Assessment – Supplier’s declaration of conformity – 

Part 1: General requirements
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Purpose of a DoC 

• Meet certain premarket requirements 

• Reduce amount of supporting data and information 

submitted to FDA

• Certify that the device was tested, and

– conforms with the FDA-recognized consensus 

standard
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Submission of DoC 

• DoC is sufficient in some cases

• Appropriate for standards with:

– Test method

– Test specifications with pass/fail criteria

– Pre-specified testing requirements or outcomes
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DoC with Supporting Documentation

• Some standards require DoC and supporting documentation

• Examples of applicable standards:

• Guidelines or Practices

• Technical Reports

• Technical Information Reports

• Provide options for methods or lack details (e.g., pass/fail criteria)

See: ISO 17050-2 Conformity assessment – Supplier’s declaration of 

conformity – Part 2: Supporting documentation
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Key Considerations for

Supporting Documentation

• Standards often provide options or choices

– more than one method may be able to assess the device

• Submission should explain:

– how the standard was used

– how it was adapted or modified to fit the device

• Was the device modified to fit the standard?

• Was the final finished device tested or not and why?
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Promissory Statement

• Testing has not been completed at time of submission

• Submitter promises to complete specific testing prior to 

marketing device

• In limited cases, FDA may accept a promissory statement

• A promissory statement is not a DoC

• Test conditions and acceptance criteria need to be described
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Summary

1. We reviewed how to find FDA-recognized standards in the standards 

database found on the FDA website

2. We provided links to relevant guidances for standards

3. We reviewed the anatomy of a standards title

4. We reviewed the Declaration of Conformity

5. We discussed where standards may be used, including the use of 

promissory statements
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Industry Education:

Three Resources for You

1. CDRH Learn: Multi-Media Industry Education

 over 125 modules

 videos, audio recordings, power point presentations, software-based “how to” modules

 mobile-friendly: access CDRH Learn on your portable devices

www.fda.gov/Training/CDRHLearn

2. Device Advice: Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics

www.fda.gov/MedicalDevices/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