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FDA/CDRH Webinar

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Donna Walsh, Senior Standards Advisor

Jianchao Zeng, Ph.D., Senior Standards Advisor

Standards & Conformity Assessment Program (S-CAP)

Office of Strategic Partnership and Technology Innovation (OST)

Division of All Hazards Response, Science and Strategic Partnerships (DARSS)

Center for Devices and Radiological Health (CDRH)

U.S. Food and Drug Administration

Recognition and Withdrawal of Voluntary 

Consensus Standards – Final Guidance

October 15, 2020
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• S-CAP Overview

• Draft guidance comments

• Final guidance

• Questions and answers

Agenda
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• S-CAP supports CDRH’s mission by driving the development, recognition, and 

appropriate use of regulatory-ready standards for medical devices throughout 

their lifecycles

• FDA encourages the voluntary use of recognized standards in premarket 

submissions

– Can increase predictability, streamline premarket review, provide clearer regulatory 

expectations, and facilitate market entry for safe and effective medical products 

– Declarations of Conformity may be used with recognized standards, reducing the amount of 

supporting data and information submitted to FDA

• ‘Recognition’: FDA’s formal identification of a standard after a determination that 

it is appropriate for manufacturers of products to declare conformance to meet 

relevant requirements

Using FDA-Recognized Standards 
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Standards in 

CDRH

S-CAP core priorities

• Standards Recognition Program 

• Encouraging the appropriate use of standards

• Active participation in national and international standards 

development 

The numbers

• 17 internal advisory Specialty Task Groups (STGs) in 23 

device/scientific areas

• ~ 400 CDRH staff participating in ~ 600 national and international 

standards committees across 29 Standards Developing Organizations

• ~1400 currently recognized standards (90%+ complete recognitions)

• 5-10% typical increase in requests for new standards development 

activities each year

• Average of 7 (range of 1-35) standards cited in each 510(k) 

submission
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• S-CAP Overview

• Draft guidance comments

• Final guidance

• Questions and answers

Agenda
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• Emphasized:

- Need for a least burdensome, clear and transparent approach to standards 

recognition

• Requested clarity on: 

- Transition periods

- Inclusion of basis for recognition and updates to the Supplemental 

Information Sheets

- The distinction between when a standard may be used in a submission 

(upon inclusion in the Consensus Standards Recognition Database) versus 

when it is formally recognized (upon publication in the Federal Register) 

Comments on the Draft Guidance
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• S-CAP Overview

• Draft guidance comments

• Final guidance

• Questions and answers

Agenda
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The final guidance outlines:

– Who may submit a request for recognition (See Section IV.B)

– FDA’s intent to respond in writing with the decision and its rationale within 60 

calendar days: recognize all, part or none of the standard (See Section IV.C)

– FDA’s obligation to publish recognition and non-recognition decisions (See 

Sections IV.C and IV.D)

• Recognized Consensus Standards Database

• Non-recognized Consensus Standards Database

Final Guidance
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• The guidance also addresses:

– Consensus standards’ value and utility in device submissions (See Section IV)

– Elements of a request for recognition (See Section IV.B)

– Supplementary Information Sheet update, including recognition rationale for all or 

part of a recognition of a standard (See Section V)

– Updating the Recognized Consensus Standards Database (See Section IV.E)

– Official recognition: upon publication in the Federal Register (See Section IV.E)

– Withdrawal of recognized standards (See Section VI)

• Possible transition periods

Final Guidance
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1. Requester’s name and electronic or mailing address 

2. Title of the standard

3. Reference number and date (of the standard)

4. Proposed list of product types for which a Declaration of 

Conformity should routinely apply

5. Basis for recognition, e.g., including the scientific, technical, 

regulatory or other basis

6. Brief identification of the testing or performance or other 

characteristics that a DOC would address 

Elements in the Request for Recognition
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• FDA formally acknowledges the request

• S-CAP considers the standard

• S-CAP convenes the appropriate Specialty Task Group to formally 

review the standard and make a recommendation to the program

– Recognize or not recognize

– Complete or partial recognition

• Based upon:

–Scientific, technical, regulatory or other basis

Recognition Decision Process
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• Recognition decision within 60 calendar days

• Decision, including rationale, sent to requester

• Pending recognition: FDA's determination (partial or complete) appears in 

the FDA Consensus Standards Recognition Database

• Official recognition: publication in the Federal Register 

• Non-recognitions listed in the Non-recognized Standards Database

** Manufacturers may submit declarations of conformity within 

their premarket submission when a standard appears in the 

Standards Recognition Database **

Recognition Decisions
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• Each recognized standard includes a Supplemental Information Sheet 

(SIS), which includes: 

– Recognition number

– Date of entry

– SDO & designation number

– US identical adoption (if applicable)

– Scope of standard

– Extent of recognition (complete or partial)

– Rationale for recognition

– Transition period (if any) 

– Relevant FDA Specialty Task Group (STG) 

Supplementary Information
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• Standard is replaced by a newer version (superseded)

• Standard is no longer appropriate for meeting a requirement

**See the Appropriate Use of Voluntary Consensus Standards 

guidance for additional information**

Withdrawal of Recognition
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• When appropriate, CDRH may implement a transition period for 

revised standards

• CDRH considers:

–Public health impact of delaying the use of a revised standard

–Difficulties manufacturers face in implementing new changes 

• Allows the submitter time to:

– Continue to test and develop without additional retesting

–Validate new test methods 

• Located in the SIS below the “Rationale for Recognition” section

Transition Periods
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Thank You

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 the Heading: How 

to Study and Market Your Device; Sub heading: Standards

Please complete a short survey about your FDA CDRH webinar 

experience. The survey can be found here

immediately following the conclusion of the live webinar
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Resources

Standards and Conformity Assessment Program: 

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

Recognition and Withdrawal of Voluntary Consensus Standards (final guidance)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal- voluntary-consensus-standards

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/ucm077

295.pdf

Device Advice: Comprehensive Regulatory Assistance: 

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

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