Standards Overview

Colleen Lee

Senior Standards Advisor, Standards Management Staff

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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Learning Objectives

• Define some key terms related to standards

• Review the authorized laws and government organizations 

involved with standards

• Learn the benefits of why FDA uses standards

• Identify and describe the different types of standards

• Discuss how CDRH uses medical device standards
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Definition of “Standard”

• Also known as "technical standard" per the Food, Drug & 

Cosmetic Act (FD&C Act)

• Common and repeated use of rules, conditions, guidelines or 

characteristics

• For products or related processes and production methods, and 

related management systems practices
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Definition of “Standard” cont:

• definition of terms

• classification or components

• delineation of procedures

• specification or dimensions

• materials 

• performance

• design

• operations

• measurements of 

quality/quantity to describe 

materials, processes, etc.

• test methods and sampling 

procedures

• description/measurement of size 

or strength
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Voluntary Consensus Standard

Definition

• a standard developed or adopted by voluntary consensus 

standards bodies, both domestic and international

Key attributes include

• due process, balance of interests, openness, appeals, 

consensus 
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National Technology Transfer and 

Advancement Act (NTTAA)

• Passed by Congress in 1995

• Signed into law on March 7, 1996

• Grew out of Department of Defense experience
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NTTAA Objective

Encourage Government Agencies to:

• Use standards developed/adopted by voluntary 

consensus bodies

instead of proprietary, non-consensus standards

• Participate in voluntary consensus standards bodies
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References

National Technology Transfer and Advancement Act

www.nist.gov/standardsgov/nttaa-act.cfm

Standards.gov 

www.nist.gov/standardsgov/index.cfm

 
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OMB Circular A-119
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OMB Circular A-119

• OMB = Office of Management and Budget

• OMB establishes policies on:

– Federal use and development of voluntary consensus 

standards 

– Conformity assessment activities

– Defined commonly-used terms
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OMB Circular A-119

• Establishes requirements for Agency participation

• Describes reporting requirements

• Describes requirements for incorporating standards 

into Agency regulations

– FDA use of standards is voluntary, unless in regulation
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OMB Circular A-119 Goals

• Eliminate government costs

• Provide incentives that serve national needs

• Encourage long-term growth for the US

• Promote economic competition
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Role of NIST

• NIST = National Institute of Standards and Technology

• Works with US industry, standards developers, and other 

government agencies to build a standards infrastructure

• Monitors and participates in standards development and 

conformity assessment
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References

OMB Circular A-119 

https://www.nist.gov/sites/default/files/revised_circular_a119_as_of_01-22-2016.pdf 

National Institutes of Standards and Technology 

www.nist.gov
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FDA Use of Standards

• 21 Code of Federal Regulation (CFR) 10.95:

• Participation in outside standard-setting activities

• FDA Policy

• addresses development and use of standards with respect to 

international harmonization of regulatory requirements and guidelines

• 60 FR 53078 (Oct. 11, 1995)

• FDA Staff Manual Guide 9100.1 

• adopted March 2007
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International Harmonization of 

Standards

FDA Goals

1. Assure that consumer protection standards and requirements 

are met

2. Facilitate availability of safe and effective products

3. Develop and use product standards

4. Minimize/eliminate inconsistent standards internationally
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FDA Staff Manual Guide

• Outlines policies/procedures to assure unified 

approach to standards

• Details responsibilities

• Describes establishment of agency-wide standards 

program
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FDA Staff Manual Guide

• Preferentially use international harmonized 

standards

• Reference standards in guidances, where appropriate

• Encourage submitters of medical device applications 

to cite standards

• Incorporate consensus standards
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References

International Harmonization; Policy on Standards; Notice 

www.gpo.gov/fdsys/granule/FR-1995-10-11/95-25070

FDA SMG 9100.1

www.fda.gov/aboutfda/reportsmanualsforms/staffmanualguides/u

cm193332.htm
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Standards in FDA Law
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FDA Modernization Act of 1997

• Revised Section 514(c)

• Added ability to formally recognize a standard, “all or 

in part”

• Added ability to accept a formal Declaration of 

Conformity
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Recognition of a Standard

• Identification of a standard to meet a requirement

• May apply to a new standard or a new version of an 

existing standard

• Recognitions posted for the public
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21st Century Cures Act of 2016

• Revised Section 514(c)

• Added timeframe for public request for FDA to 

recognize a standard

• Required FDA to respond to the requester

• Required FDA to publish basis for decision

– i.e., recognition of all, part, or none of a standard
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21st Century Cures Act of 2016

• Required FDA staff to be trained on the use of 

standards

• Required FDA to develop a guidance document 

about standards recognition process
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Standards Recognition

“by publication in the FR, recognize all or part of an appropriate 

standard established by a nationally or internationally recognized 

standard development organization for which a person may submit 

a declaration of conformity in order to meet a premarket 

requirement or other applicable requirement under this chapter to 

which such standard is applicable”

Section 514(c)(1)(A)
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Standards Recognition - cont

• If a person elects to use a standard, then they shall provide a 

declaration of conformity to that standard

• A person may elect to use data, or information other than data 

required by a standard, to meet any device requirement

Section 514(c)(1)(B)
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Standards Recognition - cont

• Notify requester of recognition request

• Make determination of extent of recognition

• Notify requester of decision and rationale

• Implement standard

Section 514(c)(1)(C)(ii-iv)
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Standards Recognition - cont

• FDA will make non-recognition decisions publicly 

available.

• FDA may withdraw recognition when a standard is no 

longer appropriate.

Section 514(c)(1)(D)
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Declaration of Conformity

• Applies to FDA-recognized standards

• May not deviate from the FDA-recognized standard

• Is a certification that a device conforms to the 

requirements identified in an FDA-recognized 

standard

 Section 514(c)(1)(A)
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Declaration of Conformity

FDA shall accept declaration of conformity unless:

1. data/information do not demonstrate that device 

conforms with standard; or

2. identified standard is not applicable

Section 514(c)(3)(A)
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Importance of Standards

• Give CDRH discretion to use standards in any process

• Build consistency, credibility, and predictability

• Are integral in execution of CDRH mission:

– Performance characteristics

– Testing methods

– Manufacturing practices
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Types of Standards

• Vertical 

• Test Methods

• National 

• Horizontal

• Material Specifications

• International 
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Vertical 

Example:

ANSI/AAMI/IEC 60601-2-25 Medical 

electrical equipment – Part 2-25: 

Particular requirements for the 

basic safety and essential 

performance of electrocardiographs

• Apply to specific devices or 

device groupings

• Prescribes specific 

procedures to evaluate 

these aspects

• CDRH has recognized several 

hundred of this type of 

standard 
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Horizontal Sterilization 

Example:

ISO 11135 Sterilization of health 

care products – Ethylene Oxide – 

Requirements for the development, 

validation, and routine monitoring 

of a sterilization process for medical 

devices.

• Apply across a wide ranges of 

devices and device types

• Built in flexibility: used across a 

range products or processes

• General principles and guidelines 

are laid out, but details are left up 

to the user

• Apply when a condition is not 

covered by a vertical standard

• CDRH has recognized several 

hundred horizontal standards
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Test Methods Procedure

1  2  3 

Example: 

CLSI M43-A Methods For 

Antimicrobial Susceptibility 

Testing for Human 

Mycoplasmas; Approved 

Guideline 

• Definitive procedure that 

produces a test result

• Test result may be used to 

assess compliance with a 

standard specification

• CDRH has recognized 

approximately 100 test 

methods 
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Material Specification

This test method 

compares burst or 

rupture strength 

of sealants on soft 

tissue. 

7.3 Number of 

Test Specimens—

Test at least 10 

specimens of 

each type. 

• Typically includes requirements for 

physical, mechanical, or chemical 

properties, and safety, quality or 

performance criteria. 

• Explicit set of requirements to be satisfied 

by a material, product, system or service. 

Example:

ASTM F2392-04(Reapproved 2015) Standard Test Method For Burst Strength of Surgical 

Sealants
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National

• Produced by US standards developing organizations

• Designated as an “ANS” or American National Standard

• Accredited through American National Standards 

Institute (ANSI)

• Example: ANSI/AAMI ES60601-1 
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International

• Developed by a harmonized international standards developing 

organization

• Examples:

– International Organization for Standardization (ISO)

– International Electrotechnical Commission (IEC)

– ASTM International 

– IEEE

– Underwriters Laboratory (UL) 
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US Adoption of

International Standards

International standard that is adopted:

• in parallel with the international SDO; or

• with changes or deviations
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Other Standards Products

Standard Practice - Defines a sequence of operations, that 

unlike a Test Method, does not produce a result. Examples: 

selection, preparation, application, etc.

Guide - An organized collection of information or series of 

options that does not recommend a specific course of action

Practice Guideline - A set of instructions for performing one or 

more specific operations that does not produce a test result.
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Where Standards May be Used

• Clinical Issue

• Labeling 

• Symbol

• Device Identifier

• Pre-Market 

• Post-Market

• Radiological Health

• Public Health Concern 

• Informed Consent, Study Subject 

Protection

• Manufacturing 

• Quality Systems Regulation

• Risk Management/Assessment

• Human Factors

• Good Laboratory Practices
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Use in Premarket Submissions

• Used in a variety of premarket submissions

• Premarket Notification (510(k) – Traditional, Abbreviated and

Special) 

• De Novo

• Premarket Approval (PMA)

• Humanitarian Device Exemption (HDE)

• Investigational Device Exemption (IDE)

• Pre-Submission

• Applicable CBER biological submission
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Summary

1. We learned the definition of a standard and its different 

types 

2. We reviewed the key pieces of legislation that formed the 

basis of the U.S. National Standards Strategy

3. We discussed the evolution of standards as used by FDA

4. We reviewed how standards are used by FDA and for 

what types of submissions they may be used 
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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