CDRH Standards

Recognition Process

CDR Scott Colburn

Director, Standards Management Staff

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Learning Objectives

• Understand how CDRH assesses & recognizes 

standards

• Identify the different types of recognition

• Find Federal Register documents on standards

• Understand how Organizations maintain Standards

• Learn how to request recognition

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CDRH Standards Program

Mission

The CDRH Standards Program was established as a result of the Food and Drug 

Administration Modernization Act (FDAMA) of 1997. The program contributes to the 

Center’s mission of protecting and promoting public health through the development and 

recognition of voluntary consensus standards that serve to establish safe and effective 

medical devices, radiation-emitting products and emerging technologies.

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CDRH Standards Program

Vision

CDRH stakeholders have access to high-quality, safe, and effective medical devices of 

public health importance first in the world through timely development and recognition of 

voluntary consensus standards. The CDRH Standards Program is the world’s leader in 

standards implementation and utilization for medical device innovation and 

manufacturing, and radiation-emitting product safety. Medical Device manufacturers, 

consumers, patients, and providers have access to voluntary consensus standards for 

medical devices and use this information to protect and promote the public health.

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Standards Management Staff

• Standards recognition/priorities

• New/current standards projects

• Travel / Travel priorities

• Standards review/ballot execution

• Liaison representatives

• Membership in SDOs

• License agreements for access to published standards

• Federal Register publications 5
Specialty Task Groups (STGs)

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• Anesthesia • Neurology

• OB-Gyn/ Gastroenterology/ 

Urology

• Ophthalmic

• Orthopedic

• Physical Medicine

• Radiology

• Software/Informatics

• Sterility

• Tissue Engineering

• Biocompatibility

• Cardiovascular

• Dental, ENT

• General I (QS/RM)

• General II (ES/EMC)

• General Hospital/General Plastic 

Surgery

• In Vitro Diagnostics

• Materials

• Nanotechnology
Specialty Task Group

Representation

ODE STG

OSEL

OSB

OCD OIR

OC

Other 

Center

OCE

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STG Duties

• identifies existing and needed standards

• prioritizes standards activities

• coordinates assessment of standard’s use to meet 

regulatory requirement

• recommends recognition of standards

• recommends liaisons, alternates, technical experts

• develops the SIS for recognized standards

• reports to SMS Director
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Standards Recognition 

“Recognition” defined in Food, Drug, and Cosmetic Act 

(FD&C) 514(c).

Describes process for FDA identification of standards 

that manufacturers of medical devices may cite to meet 

a relevant requirements in the FD&C Act.
Recognizing a Standard

SMS initiates the collection of information on: 

– Newly published standards

– Revised standards

– Title changes

– Amendments/corrigenda

– Revised editions

– Withdrawn standards

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CDRH Decisions on Standards

1. Recognition

– complete/entire standard

2. Recognition in part

– excluding certain clauses or sections

3. Non-Recognition

* may defer for future assessment

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Recognizing a Standard

• Federal Register (FR) Notice

• As described in statute, FD&C 514(c)

• Direct recognition – no need for Notice of Availability 

(NOA) and comments

• Immediately available for use by industry and regulators
Federal Register Documents

13 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm
Consensus Standards Database

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 14
Standards Maintenance

• Standards are typically up for review 3 years 

after the first publication

• Standards are reviewed for reaffirmation or 

revision every 5 years after the first 3 year cycle. 

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Requests for Recognition

• CDRH SOP for the Identification and 

Evaluation of Candidate Consensus 

Standards for Recognition

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Requests for Recognition

• Stakeholders may propose standards for recognition

• To make a request, submit

– Title of the standard

– Any reference number and date

– Name and address of the SDO

– A proposed list of devices or device types

– A brief discussion of the testing or performance or other 

characteristics that would be addressed by the standard

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Requests for Recognition

Requests to CDRH to recognize a standard may be submitted at any 

time to: 

• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

Standards/default.htm

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Request for Recognition Flow Chart

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Standards 

Recognition 

Request 

Received

Create and 

Assign Project 

Review Team

Standards 

Review and 

Assessment

Recommendation 

to STG and SMS

STG Review

STG 

Recommendation 

to SMS

SMS Prepares 

Response to 

Requestor

SMS Drafts FR

Draft FR 

Circulation for 

CDRH Clearance

FR Publication
Summary

1. We learned how CDRH assesses and recognizes standards.

2. We identified the different types of recognition.

3. We learned where FDA lists the Federal Register notices of lists 

of recognized standards.

4. We learned how different standards organizations maintain 

standards.

5. We learned how to request the recognition of a standard.

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