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 CDRH Learn: Standards Overview

 with Colleen Lee

Slide 1

Hi, I am Colleen Lee, a senior standards advisor in the standards management staff in the 

Center for Devices and Radiological Health or CDRH. In this CDRH Learn module I will discuss 

how standards became integral to the mission of CDRH and how they are used. 

Standards give the agency flexibility and discretion to use standards other than those that we 

develop ourselves. This frees the Agency to pursue other priorities. Standards also build in a 

culture of collaboration that fosters consensus, consistency and predictability. At the FDA, 

standards have become integrated as part of the execution of the agency's mission.

Slide 2

At the end of this module you will understand what is a standard, what it is not and what is a 

voluntary consensus standard. I will provide you an overview of the key pieces of legislation 

that form the basis of the U.S. national standards strategy. I will discuss the evolution of 

standards used by the FDA as well as explain the different types of standards. Lastly, you will 

learn how standards are used in CDRH on a daily basis. 

Slide 3

The word standard calls to mind many definitions, but this module will focus on how FDA views 

standards in light of our regulatory authority. Specifically, the term standard or technical 

standard is found in the Food Drug & Cosmetic Act or FD&C Act. This definition includes 

common and repeated use of rules, conditions, guidelines or characteristics. Standards are 

used for products, production methods and related management systems practices. 

Slide 4

Standards include many aspects such as a definition, a classification system, a series of 

procedures, a specification for size or dimension, a material, a performance feature, a design or 

how something operates. Standards can describe a process, a system, a service, a practice, or 

a specific product. Standards may be written to outline a specific test method, a sampling plan, 

or a way to measure size or strength. 

Slide 5

Throughout this module, we'll refer to "voluntary consensus standards" which is a standard 

developed or adopted by voluntary consensus standards bodies, both domestic and 

international. Key attributes to the development of standards are due process, balance of 

interests, openness of committee proceedings, an appeals process and consensus.

Slide 6 

In 1995, Congress passed the National Technology Transfer and Advancement Act, or NTTAA. 

This Act was signed into law in 1996 and grew out of the Department of Defense experience 

with regards to military specifications.

Slide 7

The Act specifically encouraged government agencies like the FDA to use standards developed 

by voluntary consensus bodies instead of creating proprietary, non-consensus standards. The 

Law also encouraged Agencies to participate and collaborate with interested parties in the 

standards development process. 
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Slide 8

Here are the links to the NTTAA legislation and the National Institutes of Standards and 

Technology (NIST) websites. The first link discusses how the Act is interpreted and 

administered, and the second is a central location for standards activity in the U.S.

Slide 9

A formal foundation to our work in standards is laid out in the government document OMB 

Circular A-119. 

Slide 10 

OMB stands for the Office of Management and Budget which is housed in the Executive Branch 

of the White House. In February of 1998, OMB published Circular A-119 which established 

policies for Federal agencies to follow in the development of voluntary consensus standards. It 

provided the original framework on conformity assessment activities, and provided definitions of 

commonly used terms such as "standards", and "voluntary consensus standards."

Slide 11 

The circular set forth requirements for Agency participation on standards committees and 

working groups, which includes a reporting requirement to Congress on an annual basis. The 

circular also sets forth requirements for incorporation of standards into Agency regulations. 

When standards are used at FDA, their use is voluntary. The only exception is when a standard 

is incorporated by reference into a regulation. When that occurs, and this is very rare, the 

standard becomes mandatory.

Slide 12 

The goals in the circular include the elimination or reduction of government costs that would be 

incurred if Agencies were to write their own standards. This provides an incentive for Agencies 

to write standards that serve the national interests, to encourage long-term economic growth for 

the US, and to promote competition in the marketplace. 

Slide 13

As mentioned earlier, the NTTAA directs Federal agencies to adopt or recognize standards that 

were created in the private sector instead of creating government-unique standards. NIST 

coordinates the Federal, State, and local governments' reliance on voluntary standards and 

decrease dependency on internally-developed standards.

Slide 14

Here are links to OMB Circular A 119 and to the NIST websites. These sites give further 

background on the implementation the US National Standards Strategy.

Slide 15

How FDA approaches the use of standards is outlined in three key documents listed here - the 

Code of Federal Regulations or CFR, FDA Policy documents, and the FDA Staff Manual Guide. 

FDA published its position with regards to standards work and international harmonization for 

the first time in the Federal Register on October 11, 1995.

Slide 16

In this first FR Notice, FDA included a number of goals relating to standards work. The first goal 

is to ensure that consumer protection standards and requirements are met. The second goal is 

to facilitate the availability of safe and effective products to the market place. The third goal is to 

develop and use product standards. 
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The final goal is to minimize or eliminate inconsistent international standards as standards 

developers work toward harmonization - where participating countries agree on the key 

components in the standard and adopt them in their home countries. For us here in the US, it is 

termed the US adoption of an international standard. 

Slide 17

The third of these documents, the Staff Manual Guide, outlines policies and procedures to 

assure a unified approach to standards within the FDA. It details employees’ responsibilities as 

participants in standards development nationally and internationally. It also describes the 

establishment of an agency-wide Standards Management Program.

Slide 18 

FDA will preferentially use international, harmonized standards. Also, whenever FDA releases 

draft or final guidance documents, FDA may cite standards where needed. In turn, submitters 

of medical device applications may cite standards in their submissions. Finally, the staff manual 

guide states that FDA can incorporate consensus standards within its processes or regulation 

when appropriate. 

Slide 19

Here are the links to the FR Notice on International Harmonization of Standards and FDA Staff 

Manual Guide 9100.1 outlining what we have just discussed. 

Slide 20

Thus far, we defined a standard, a voluntary consensus standard and shared an overview of the 

legislation that formed the US Standards Strategy. After our brief review of the evolution of 

standards-setting activity at the FDA, we can begin our discussion of how standards are used at 

FDA through the passage of various laws.

Slide 21

Let's first talk about the FDA Modernization Act of 1997. This Act significantly changed Section 

514(c) of the Food Drug and Cosmetic Act in that it allowed for the formal recognition of a 

standard and added a procedure for accepting a declaration of conformity. These were major 

revisions and we will define recognition of a standard first. 

Slide 22

The term "recognize" or "recognition" refers to FDA's identification of standards as appropriate 

to use in a medical device submission to satisfy a requirement. When FDA recognizes a new 

standard or a new version of an existing standard, the notice is made available through 

publication in the Federal Register and through the FDA Recognized Consensus Standards 

Database on the FDA website. 

Slide 23

In December 2016, Congress passed the 21st Century Cures Act, which among other 

milestones, modified section 514(c) of the FD&C Act. The Cures Act added a timeframe for FDA 

action on a request for recognition of an appropriate standard. The Law also required FDA to 

state the basis for its decision. 
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Slide 24

The Act required all FDA employees who review premarket submissions to receive training on 

standards, and for FDA to develop a guidance document about the standards recognition 

process. These requirements enhance the current processes as well as increase transparency 

on FDA's decision to recognize standards. 

Slide 25

Section 514(c) states that we will "by publication in the Federal Register, recognize all or part of 

an appropriate standard that has been established by a nationally or internationally recognized 

standard development organization for which a person may submit a declaration of conformity." 

Slide 26 

Further, if a person elects to use a standard, that person shall provide a declaration of 

conformity to the standard. Along with the declaration, a person may use data, or information 

other than data, to meet the requirement. This allows the submitter and FDA to assess the 

extent of conformity with the standard. 

Slide 27 

FDA will confirm receipt of a recognition request by issuing an acknowledgement letter to the 

person or entity who made the request. Once a decision has been reached, FDA will send a 

written response to the requestor that includes the basis of the decision. The basis will 

generally be scientific, technical, or regulatory in nature. 

Slide 28 

As mentioned earlier, standards recognitions are publically available via the Federal Register 

and the Recognized Consensus Standards database. As a result of the 21st Century Cures Act, 

FDA will make any non-recognition decisions available through the Federal Register in the 

same manner, except that non-recognitions will be posted to their own web page.

FDA may withdraw recognition of out-of-date or older standards that are no longer published, or 

standards that no longer meet a requirement. 

Slide 29

Earlier, we discussed the FDA Modernization Act of 1997 which allowed for the formal 

recognition of a standard and instituted a procedure for accepting a declaration of conformity. A 

Declaration of Conformity to an FDA-recognized consensus standard is used when a submitter 

of a medical device application states that its device conforms to all of the requirements of that 

standard without deviation. The purpose is to certify - so to speak - that the device met certain 

premarket requirements and thereby reduces the amount of supporting data and information 

that is submitted to FDA. 

Slide 30

FDA will accept a declaration of conformity to a standard after it is recognized. This recognition 

occurs when FDA publishes a notice in the Federal Register. FDA will accept a declaration of 

conformity unless the data or information don't demonstrate that the device conforms with the 

standard; or if the identified standard is not applicable. 

Slide 31

Thus far, we've defined standards, we've outlined the US standards strategy, and we've 

described the standards-related laws including the 21st Century Cures Act. We're now ready to 

discuss how standards are used at CDRH on a day-to-day basis.
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The use of consensus standards can increase predictability, streamline premarket review, 

provide clearer regulatory expectations, and facilitate market entry for safe and effective medical 

products. Consensus standards provide a group approach to certain aspects of device 

evaluation, such as testing methods, pass or fail performance criteria, and processes to address 

risk management and usability. For decades, CDRH has supported and relied on the 

development and use of consensus standards to support the Agency's mission in protecting and 

promoting the public health. 

Slide 32 

There are many types of standards such as vertical and horizontal standards, test methods and 

material specifications, and national and international standards. Over the next few slides, let 

me describe these in detail. 

Slide 33

Vertical standards apply to a specific device or device grouping. These standards typically call 

out specific test methods or performance aspects of a specific grouping of devices. CDRH has 

recognized several hundred vertical standards. An example of a vertical standard specific to 

electrocardiographs or EKGs is listed here on the slide. 

Slide 34

In contrast to vertical standards, Horizontal standards may be applied across a wide range of 

devices and device types. There is built in flexibility that may apply when a condition is not 

covered by a vertical standard. These types of standards include biocompatibility, sterilization, 

materials, software and informatics. CDRH has recognized several hundred horizontal 

standards. An example of a horizontal standard addressing sterilization for medical devices is 

listed on the slide. 

Slide 35 

Standards may be written as a test method with a specific procedure that produces a test result. 

This result may then be used to assess compliance with a standard specification. CDRH has 

recognized approximately 100 test methods. An example of a test method specific to 

determining susceptibility to antimicrobials is listed on the side. 

Slide 36

Material specifications are a set of requirements that may be physical, mechanical or chemical 

in nature. The specification may be achieved by a design feature, a system, or a service. An 

example of a test method for burst strength of a surgical sealant is listed on the slide. 

Slide 37

A U.S. national standard can be identified in several ways. It may be published by ANSI with 

"ANS" or "ANSI" in the title of the standard. ANS stands for the American National Standard, 

and ANSI is the American National Standards Institute. In addition, a US standards developing 

organization, or SDO, may also publish a national standard. ANSI accredits SDO's using the 

ANSI Essential Requirements. In this case, the national standard is identified as ANSI along 

with the SDO as shown in this example.

Slide 38 

International standards are standards developed by international standards organizations. 

International standards are available for consideration and use worldwide. 
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The most common organizations are the International Organization for Standardization (ISO) 

and the IEC, or International Electrotechnical Commission. Others include ASTM International, 

IEEE and UL, or Underwriters Laboratories among several others.

Slide 39

ANSI has procedures for an American standards developer that wishes to adopt an ISO or IEC 

standard, and this adoption can take the form of an identical national adoption or a modified 

adoption of the standard. 

Slide 40 

Other types of standards products include standard practices, guides, or other practice 

guidelines. These products typically do not include normative requirements or referenced 

sections in a standard. Instead they include a set or collection of information or options that may 

not necessarily recommend a specific course of action as would a standard. A short description 

of each of these standards products is included here. 

Slide 41

Standards may be used in a variety of processes as described on this slide. Most Standards 

typically do not satisfy all the required elements of a premarket submission. It's important to 

understand that FDA recognition of a standard does not supersede other aspects of the FD&C 

Act and the regulations for marketing or investigating medical devices in the U.S.

Slide 42

Consensus standards are used in a variety of premarket submission types to facilitate their 

review. These include 510(k), De Novo, premarket approvals, humanitarian device exemptions, 

investigational device exemptions, and pre-submissions. Also, standards may be used in 

applicable submissions regulated by the Center for Biologics Evaluation and Research. 

Submitters may choose to conform to applicable consensus standards or address issues 

relevant to approval or clearance in another manner.

Slide 43

Let's recap what we reviewed in this module. 

First, we learned the definition of a standard and its different types. We reviewed the key pieces 

of legislation that formed the basis of the U.S. National Standards Strategy. We discussed the 

evolution of standards and how standards are used by FDA and specifically CDRH on a daily 

basis.

Slide 44

Thank you for your attention to this CDRH Learn Module on the Overview of the Standards 

Program. We encourage you to use other industry education resources we've developed 

especially for you, as shown on this slide. Thanks for watching this program and we'll see you 

next time.

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