Contains Nonbinding Recommendations 
Appropriate Use of Voluntary 
Consensus Standards in Premarket 
Submissions for Medical Devices 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on September 14, 2018. 
 
The draft of this document was issued on May 13, 2014. 
 
This document supersedes Guidance for Industry and FDA Staff; Recognition 
and Use of Consensus Standards, issued on September 17, 2007, Frequently 
Asked  Questions  on  Recognition  of  Consensus  Standards,  issued  on 
September 17, 2007, and Guidance for Industry and for FDA Staff: Use of 
Standards in Substantial Equivalence Determinations, issued on March 12, 
2000. 
 
For questions about this document regarding CDRH-regulated devices, contact the Office of the 
Center Director at 301-796-5900; or Scott Colburn at 301-796-6287 or by e-mail at 
scott.colburn@fda.hhs.gov.  
 
For questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.  
 
   
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research 
  Contains Nonbinding Recommendations 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2014-D-0456. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
CDRH 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 
17019 to identify the guidance you are requesting. 
 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER) 
by written request, Office of Communication, Outreach, and Development (OCOD), 10903 New 
Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or 
240-402-8010, by email, ocod@fda.hhs.gov, or from the Internet at  
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guid
ances/default.htm. 
 
ii  Contains Nonbinding Recommendations 
Table of Contents 
 
I.  Introduction ............................................................................................................................. 1 
II.  Background .......................................................................................................................... 1 
A.  The National Technology Transfer and Advancement Act (NTTAA) ............................ 2 
B.  The Food and Drug Administration Modernization Act and 21st Century Cures Act ..... 2 
III.  Scope .................................................................................................................................... 3 
IV.  Use of Consensus Standards ................................................................................................ 3 
A.  Use of Declarations of Conformity .................................................................................. 5 
B.  General Use of Consensus Standards ............................................................................... 9 
V.  Managing Product Development When Standards Change: Transition Periods ............... 10 
A.  Where to Find Information on a Transition Period ........................................................ 10 
B.  When Standards Change Prior to Review of a Premarket Submission .......................... 10 
C.  When Standards Change During Active Review of a Premarket Submission ............... 11 
D.  Transition Period Expiration .......................................................................................... 11 
VI.  Promissory Statements ....................................................................................................... 11 
VII.  Limitations of Consensus Standards .................................................................................. 12 
VIII.  When Devices or Standards Change After Marketing Authorization ............................ 12 
 
iii  Contains Nonbinding Recommendations 
Appropriate Use of Voluntary 
Consensus Standards in Premarket 
Submissions for Medical Devices 
Guidance for Industry and  
Food and Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page.  
I.  Introduction 
The Food and Drug Administration (FDA) developed this document to provide guidance to 
industry and FDA staff about the appropriate use of national and international voluntary 
consensus standards (referred to as consensus standards) in the preparation and evaluation of 
premarket submissions for medical devices.   
 
For the current edition of the FDA-recognized standard(s) referenced in this document, see the 
FDA Recognized Consensus Standards Database Web site at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.   
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required. 
II.  Background 
Voluntary consensus standards can be a valuable resource for industry and FDA staff.  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 consensus approach to certain aspects of the evaluation of device 
safety and effectiveness, such as testing methods, acceptance criteria, and processes to address 
areas such as risk management and usability.  The use of consensus standards can also promote 
international harmonization.  For decades, FDA has supported and relied on the development and 
  1  Contains Nonbinding Recommendations 
use of consensus standards to support the Agencys mission in protecting and promoting the 
public health. 
A.  The National Technology Transfer and Advancement Act 
(NTTAA) 
In 1996, Congress passed the National Technology Transfer and Advancement Act (NTTAA) 
(Pub. L. No. 104-113), codifying an Office of Management and Budget (OMB) directive, Circular 
A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and 
in Conformity Assessment Activities, that had previously been issued several times, dating back 
to the late 1970s.1  The NTTAA and OMB Circular A-119 established Federal government 
policies to improve the internal management of the Executive Branch by directing agencies to use 
voluntary consensus standards in lieu of government-unique standards except where voluntary 
consensus standards are inconsistent with law or otherwise impractical.2 
B.  The Food and Drug Administration Modernization Act and 21st 
Century Cures Act 
Congress also enacted the Food and Drug Administration Modernization Act of 1997 (FDAMA) 
(Pub. L. No. 105-115) and the 21st Century Cures Act (Pub. L. 114-255), which amended section 
514(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 514(c) states, in part, 
that FDA shall, by publication in the Federal Register . . . 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 submission requirement or other requirement, 21 U.S.C. 360d(c)(1)(A). 
 
The term recognize in section 514(c) of the FD&C Act refers to FDAs formal identification of 
a standard after a determination that it is appropriate for manufacturers of products to declare 
conformance to meet relevant requirements in the FD&C Act, including premarket submission 
requirements. 
 
This guidance refers to voluntary consensus standards recognized by FDA in the Federal Register 
in accordance with section 514(c) of the FD&C Act as FDA-recognized consensus standards. A 
list of consensus standards that FDA has recognized or decided to recognize is available on the 
FDA Recognized Consensus Standards Database Web site.3 See section IV for more information 
about standards that FDA has decided to recognize but for which recognition is still pending. 
 
Use of consensus standards to meet premarket submission requirements can help facilitate the 
premarket review process and is not limited to use in Abbreviated Premarket Notifications 
(510(k)s), but can also be used for any 510(k), De Novo request, Investigational Device 
Exemption (IDE) application, Premarket Approval (PMA) application, Product Development 
Protocol (PDP), Humanitarian Device Exemption (HDE) application, Investigational New Drug 
                                                           
1 See more information at https://www.nist.gov/standardsgov/what-we-do/federal-policy-standards/key-federal-
directives. 
2 Pub. L. No. 104-113, 110 Stat. 775, 783,  12(d) (March 7, 1996). 
3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
  2  Contains Nonbinding Recommendations 
(IND) Application, or Biologics License Application (BLA) for those devices that are regulated 
by CBER as biological products under section 351 of the Public Health Service (PHS) Act.  
However, in most cases the standards would only satisfy part of the submission requirements.  In 
addition, submitters may choose to conform to applicable consensus standards or address issues 
relevant to approval or clearance in another manner.4  Regardless of the decision a submitter 
ultimately makes about the use of consensus standards, submitters should make sure their 
premarket submissions contain all necessary information, as required by the FD&C Act and its 
implementing regulations.5 
III.  Scope 
This guidance describes the appropriate use and documentation of both FDA-recognized and non-
recognized consensus standards for premarket submissions and how FDA staff intends to rely on 
consensus standards during the review process.  This guidance provides further clarity and 
explanation about the regulatory framework, policies, and practices regarding the appropriate 
utilization of consensus standards for premarket submissions.  This guidance is applicable to all 
articles that meet the definition of a device under section 201(h) of the FD&C Act. 
 
Under section 514(c) of the FD&C Act, conformity with consensus standards can fulfill 
requirements other than premarket submission requirements; this use is not discussed in this 
guidance.  This guidance also does not address the specific content required in a particular 
premarket submission. Additionally, this guidance does not address consensus standards that are 
incorporated by reference (IBR) into regulations (e.g., 21 CFR 830.10, Incorporation by reference 
regarding requirements for a Unique Device Identifier).  For additional information, see the 
Standards Incorporated by Reference Database Website.6 
IV.  Use of Consensus Standards 
This section discusses procedures for the appropriate use of consensus standards, the content of a 
Declaration of Conformity (DOC) to consensus standards that FDA has recognized or decided to 
recognize, and the general use of standards when the use of a DOC is not appropriate for purposes 
of premarket submissions. 
 
The use of consensus standards is not mandatory for medical device premarket submissions 
unless the consensus standard has been incorporated by reference into a regulation.  A 
manufacturer may choose to rely on applicable consensus standards or address issues relevant to 
approval or clearance in another manner.  As discussed below, if a manufacturer chooses to 
submit a DOC under section 514(c)(1)(B) of the FD&C Act, the declaration must be truthful.7 
                                                           
4 In the context of this guidance, submitter may refer to the holder of a premarket submission, manufacturer, 
sponsor, or applicant. 
5 In the case of a device regulated as a biologic under a BLA by CBER, additional information may be required under 
the PHS Act. 
6 https://standards.gov/sibr/query/index.cfm 
7 Under section 301(x) of the FD&C Act, the falsification of a Declaration of Conformity submitted under section 
514(c) of the FD&C Act is a prohibited act.  Under section 501(e)(2) of the FD&C Act, a device is adulterated if, 
among other conditions, it is declared to be in conformity with a recognized consensus standard unless the device is 
in all respects in conformity with such standard. 
  3  Contains Nonbinding Recommendations 
 
It is important for industry and FDA staff to be aware that the use of consensus standards 
generally satisfies only a portion of a premarket submission.  A submitters use of consensus 
standards may not on its own provide a sufficient basis for regulatory decisions.  For example, a 
specific device may raise safety and/or effectiveness questions not addressed by any FDA-
recognized consensus standard or a specific FDA regulation may require additional information 
beyond what the FDA-recognized consensus standard provides.  In other words, even when a 
premarket submission appropriately demonstrates conformity with one or more consensus 
standards, such conformity may not satisfy all requirements under the FD&C Act and its 
implementing regulations for marketing or investigating the product in the United States.  FDA 
evaluates the totality of each submission to determine whether it contains all necessary 
information and meets the requirements for marketing or investigating the product in the United 
States. 
 
FDAs experience with premarket submissions indicates that submitters do not always use 
consensus standards appropriately.  For example, submitters may use a version of a consensus 
standard that FDA does not recognize, or they may not realize that only certain aspectsnot all
of a particular consensus standard have been recognized by FDA.8  In addition, submitters 
sometimes attempt to use consensus standards that do not apply to the particular type of device or 
testing performed.  When submitters do not use consensus standards appropriately, it is often 
necessary for FDA staff to request additional information to address the issue(s) the standard was 
intended to address. 
 
Appropriate use of consensus standards can be effective in demonstrating individual aspects of 
safety, effectiveness, or substantial equivalence in the premarket process.  When used 
appropriately, consensus standards will typically reduce the amount of documentation that a 
submitter needs to provide and may reduce FDA review time. 
 
There are two appropriate uses of consensus standards in the premarket process: Declaration 
of Conformity in accordance with section 514(c)(1)(B) of the FD&C Act and general use. 
 
A DOC may refer only to standards for which FDA has assigned a recognition number.  Such 
standards are those that FDA has recognized by notice published in the Federal Register or that 
FDA has decided to recognize but for which recognition is pending (because a periodic notice has 
not yet appeared in the Federal Register).  A submitter may consult FDAs online database for 
Recognized Consensus Standards to determine whether a DOC may refer to a particular standard.  
The database will provide the most up-to-date list of suitable standards because, after FDA has 
decided to recognize a standard, we will update our online database to reflect the decision even 
before recognition of the standard.  The database will include a recognition number and a 
Supplemental Information Sheet (SIS) for each decision, including for cases for which 
recognition is pending.    
 
                                                           
8 FDA recognizes specific versions of a consensus standard, and the recognized version may not always be the most 
current or be for all clauses of a standard. Please refer to the  consensus standard database Web site, 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm that contains supplementary information. 
 
  4  Contains Nonbinding Recommendations 
A DOC to a consensus standard may be used when a submitter certifies that its device conforms 
to all of the requirements of a consensus standard that FDA has recognized or decided to 
recognize.9  In a DOC, the submitter may not deviate from the consensus standard that FDA has 
recognized or decided to recognize.10 
 
General use of a consensus standard in premarket submissions refers to situations where a 
submitter chooses to conform to a consensus standard, in part or in whole, but does not submit a 
DOC.  Also, a submitter may not submit a DOC if the submitter chose to rely on a consensus 
standard that FDA has not recognized or decided to recognize, or the submitter has deviated from 
an FDA-recognized consensus standard. 
A.  Use of Declarations of Conformity 
The purpose of declaring conformance with a consensus standard that FDA has recognized or 
decided to recognize is to use such conformance to meet certain premarket requirements and 
reduce the amount of supporting data and information that are submitted to FDA.  Thus, under 
section 514(c)(1)(B) of the FD&C Act, a submitter who chooses to rely on a consensus standard 
in a DOC to meet a premarket submission requirement must at the time of the submission certify 
that the device is in conformity with the consensus standard that FDA has recognized or decided 
to recognize so that FDA may determine in its review whether the submission meets applicable 
premarket requirements.  FDA expects that all necessary testing required by the consensus 
standard will be performed and conformance to the consensus standard will be met prior to 
sending the premarket submission.  To certify conformance with a consensus standard, the 
submitter must submit a DOC (see section 514(c)(1)(B) of the FD&C Act).  These elements of a 
DOC11 are consistent with ISO/IEC 17050-1 Conformity assessment  Suppliers declaration of 
conformity  Part 1: General requirements and ISO 17050-2 Conformity assessment  Part 2: 
Supporting documentation for the general requirements and supporting documentation needed 
for the submission of a DOC to a consensus standard. 
 
When submitters are interested in making a DOC to a consensus standard, and the device type is 
not included within the scope of that standard and is not listed in the SIS, the submitter should 
explain why that consensus standard is appropriate for the device in question.  In most 
circumstances, the scope of the standard defines what is to be tested, whether that is the device 
itself, or an attribute of that device, e.g., the devices material composition/properties or 
packaging.  FDA recommends that most testing be conducted on a final finished device.  
Finished device under 21 CFR 820.3(l) means any device or accessory to any device that is 
suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.  In 
contrast, a final finished device is a device that includes all manufacturing processes for the to be 
marketed device, including packaging and sterilization, if applicable. If the tested device is not 
the final finished device the submitter intends to market, the submitter should provide a 
justification for any differences that may impact performance of the tested device compared to the 
final finished device to be marketed.  The DOC may be based on data or information provided by 
                                                           
9 See section 514(c)(1)(B) of the FD&C Act. 
10 See sections 301(x) and 501(e)(2) of the FD&C Act. 
11 ISO/IEC Guide 22:1996 General criteria for suppliers declaration of conformity was revised and replaced 
by ISO/IEC 17050-1:2004.  See https://www.iso.org/iso/catalogue_detail.htm?csnumber=27569.  
  5  Contains Nonbinding Recommendations 
the component manufacturer(s), but it is the responsibility of the submitter to ensure the accuracy 
of the information.  In these instances, FDA recommends that submitters consult with the 
appropriate FDA staff prior to initiating testing.  Information for requesting feedback may be 
found in the guidance titled Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with FDA Staff.12 
A submitter may base a DOC on testing and analysis performed in-house or on testing performed 
by a third party, such as a testing laboratory or certification body.  If a submitter used a third 
party, the submitter should provide the name and address of each testing laboratory or 
certification body that was involved in determining the conformance of the device with the 
applicable consensus standard(s) that FDA has recognized or decided to recognize and reference 
any accreditations of those organizations. 
Although accompanying test data is not required to be submitted with a DOC, FDA may request, 
at any time, the data or information relied on by the submitter to make a DOC to a consensus 
standard (see section 514(c)(3)(B) of the FD&C Act).  However, these requests should only occur 
in certain cases, as described below in sections IV.A(2) and (3) of this guidance.  The submitter 
must maintain all records that include data and information demonstrating conformity, whether 
based upon third-party or in-house testing, to the consensus standard that FDA has recognized or 
decided to recognize in accordance with the Quality System Regulation (21 CFR part 820).  Such 
records are part of the design history file for the device and are subject to inspection in 
accordance with 21 CFR 820.180. 
Falsifying a DOC to a consensus standard is a prohibited act under section 301(x) of the FD&C 
Act.  If a DOC to a consensus standard has been falsified, or if the device does not conform to the 
standard as declared, purported, or represented, the device would be deemed adulterated under 
section 501(e)(2) of the FD&C Act.  Also, intentionally or unintentionally falsifying a DOC to 
obtain device clearance or approval is a prohibited act under section 301(q)(2) of the FD&C Act.   
(1) Elements of a Declaration of Conformity
The elements that should be in a DOC are listed below.  A submitter may choose to create a DOC 
using the format as described in ISO/IEC 17050-1 Conformity Assessment  Suppliers 
declaration of conformity  Part 1: General requirements.  The elements that should be included 
are: 
a. Name and address of the applicant/sponsor responsible for the DOC
b. Product/device identification, including product codes, device marketing name, model
number and any other unique product identification data specific to the DOC in
question
c. Statement of conformity
d. A list of standards for which the DOC applies including, for each standard, the options
selected, if any
e. The FDA recognition number for each standard
f. The date and place of issuance of the DOC
12 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-
submissions-q-submission-program 
6  Contains Nonbinding Recommendations 
g.  Signature, printed name, and function of the sponsor responsible for the DOC 
h.  Any limitation on the validity of the DOC (e.g., how long the declaration is valid, what 
was tested, or concessions made about the testing outcomes) 
(2)  Supplemental Documentation to Support a Declaration of 
Conformity 
 
Not all consensus standards that FDA has recognized or decided to recognize are appropriate for 
DOCs without the submission of supporting documentation that describes how the device 
conforms to the consensus standard.  It is important to restate that the use of consensus standards 
may satisfy only a portion of a premarket submission and conformance to a standard on its own 
may not provide a sufficient basis for a regulatory decision.  Many consensus standards that FDA 
has recognized or decided to recognize, while useful in the premarket process, are too general and 
broad in scope for FDA to determine whether conformance to the applicable consensus standard 
has been met or whether conformance to the consensus standard alone is sufficient to make a 
regulatory decision, unless FDA also reviews the underlying data or supporting documentation.  
Types of consensus standards where review of the underlying data may be necessary may include 
standards that are horizontal, are process-oriented, or that include choices relating to test methods, 
test selection, or have guidelines that apply to a broad range of device types and safety issues.  An 
example is ISO 14971 Medical devices  Application of risk management to medical devices.  
These consensus standards typically do not list all of the detailed acceptance criteria for the 
necessary performance tests.  In cases where the consensus standard is not well-suited for a DOC 
without the submission of supporting documentation, the FDA recommends that submitters 
follow ISO/IEC 17050-2 Conformity assessment  Suppliers declaration of conformity  Part 2: 
Supporting documentation.  In brief, if a premarket submission contains a DOC to such a 
consensus standard, FDA recommends including a summary test report that includes test results.  
Similarly, for consensus standards that describe test methods, a process, or consists of guidelines, 
but do not provide specific acceptance criteria for all of the necessary performance tests, the 
supporting documentation should be submitted, for example, ANSI/AAMI/IEC 60601-1-2 
Medical electrical equipment  Part 1-2: General requirements for basic safety and essential 
performance  Collateral standard: Electromagnetic compatibility  Requirements and tests. 
 
Many standards, called parent standards, have accompanying consensus standards (e.g., IEC 
collateral13 and particular14 standards, or standards within a series such as ANSI/AAMI/ISO 
80369 Small-bore connectors for liquids and gases in healthcare applications series) that provide 
acceptance criteria for the testing of specific types of devices (e.g., ANSI/AAMI/ISO 80369-3 
Small-bore connectors for liquids and gases in healthcare applications  Part 3: Connectors for 
                                                           
13 An IEC collateral standard is defined as a standard that addresses additional basic safety and essential 
performance requirements that are common to a subgroup of medical electrical equipment; or a standard that 
addresses additional basic safety and essential performance requirements that deal with characteristics of medical 
electrical equipment or medical electrical systems that are not fully covered by the general standard. See 
ANSI/AAMI ES60601-1:2005/(R) 2012 and A1 2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated 
Text): Medical electrical equipmentPart 1: General requirements for basic safety and essential performance 
(IEC 60601-1:2005, MOD). 
14 An IEC particular standard is defined as a standard that addresses additional basic safety and essential performance 
requirements that deal with characteristics of particular medical electrical equipment that are not covered by the 
general standard.  
  7  Contains Nonbinding Recommendations 
enteral applications).  These accompanying consensus standards, if recognized by FDA, may be 
appropriately suited for DOCs without submission of underlying data. 
(3)  FDA Review of Declarations of Conformity and 
Supplemental Documentation 
 
During review of a premarket submission in which a DOC has been submitted, FDA will review 
the DOC and determine whether the following have been met: 
 
a.  The elements in this guidance, ISO/IEC 17050-1, or equivalent, of a Declaration of 
Conformity are present. 
b.  The standard(s) identified in the DOC has (have) a recognition number.15 
c.  There have been no deviations made to the normative part of the consensus standard(s) 
identified. 
d.  The consensus standard(s) identified in the DOC is (are) applicable to the medical device 
under review.16 
e.  The supportive documentation, if determined to be necessary per ISO/IEC 17050-1, is 
provided according to ISO/IEC 17050-2 or equivalent (see Table 1 below).  
f.  The data or information submitted to support such declaration demonstrates that the 
device is in conformity with the normative section of the standard.17 
g.  The DOC does not include a promissory statement (See Section VI).18 
If any of the elements above are not met, FDA will review any explanation provided by the 
sponsor to determine if it is adequate to support the DOC or will request additional information to 
meet the requirements.  
 
As outlined above, there are circumstances when supplemental documentation is necessary to 
support a DOC. The type of information a sponsor should submit and the FDA needs to review as 
supplemental documentation will vary based on the specific consensus standard; however, the 
following general principles should govern the need for and review of supplemental 
documentation: 
  When the consensus standard includes both a test method or test procedure with a single 
set of predefined acceptance criteria, FDA should generally not request the data relating to 
the specific consensus standard identified in the DOC. 
  When the consensus standard describes a test method or procedure, but does not include 
acceptance criteria, the submitter should provide an assessment of the results and how 
conformity was determined.    
  When the consensus standard includes choices related to, for example, what is to be tested, 
which test methods to use, or acceptance criteria to assess conformity, the submitter 
should include an explanation for the choices and selections made.   
 
                                                           
15 See section 514(c)(1)(B) of the FD&C Act. 
16 See section 514(c)(3)(A)(ii) of the FD&C Act. 
17 See section 514(c)(3)(A)(i) of the FD&C Act. 
18 See section 514(c)(1)(B) of the FD&C Act. 
 
  8  Contains Nonbinding Recommendations 
Table 1 further outlines FDAs expectations regarding submission of supplemental documentation 
for different types of consensus standards that FDA has recognized or decided to recognize. 
 
Table 1. FDA Review of Declarations of Conformity and Supplemental Documentation19 
Type of Consensus Standard for  Should submission 
Should submission 
include supplemental 
which a DOC might be provided in a  include complete test 
documentation per 
premarket submission  report?  ISO/IEC 17050-2? 
Design Standard   No  No 
Standard Includes     
Test Method(s) or  Acceptance 
   
Procedure(s)  Criteria 
Yes, criteria/ 
Included  Not included  No 
summary results 
Not included  Included  No  Yes 
Included  Included  No  No 
Yes, complete test 
Not included  Not Included  Yes 
report  
B.  General Use of Consensus Standards 
General use of a consensus standard in premarket submissions refers to situations where a 
submitter chooses to conform to a consensus standard, in part or in whole, but does not submit a 
DOC.  Reasons for general use of a consensus standard vary, but may include: (1) the 
manufacturer has chosen to use a recognized consensus standard without submitting a DOC; (2) 
the manufacturer has made changes to the consensus standard methodology (i.e., deviations), 
relative to what FDA has recognized or decided to recognize, to adapt its purpose to test the 
device; or, (3) the manufacturer has chosen to use a consensus standard that does not have a 
recognition number (e.g., because there is no consensus standard applicable to the device type that 
FDA has recognized or decided to recognize).  When a manufacturer is citing the general use of a 
voluntary consensus standard as discussed above, we recommend that the basis of such use be 
included along with the underlying information or data that supports how the standard was used.  
 
                                                           
19 Although Table 1 represents FDAs general approach, consistent with section 514(c)(3)(B) of the FD&C Act, FDA 
may request, at any time, the data or information relied on by a person to make a declaration of conformity with 
respect to a recognized standard. 
  9  Contains Nonbinding Recommendations 
V.  Managing Product Development When Standards 
Change: Transition Periods 
As FDA and industry recognize the need to improve device performance or address noted safety 
issues, consensus standards may become obsolete or need updating to reflect current knowledge.  
FDA recognizes that changes to existing standards may affect the lifecycle of device 
development, and the Agencys recognition of an updated version of an existing consensus 
standard or the recognition of a different consensus standard altogether, without an approach to 
manage this transition, may delay product development. 
 
When a consensus standard has been replaced by a newly recognized standard, the older version 
will be withdrawn following a transition period.  The transition period is intended to decrease the 
burden of implementing a shift from one version of a consensus standard to a newer version.  
Such a transition period allows the submitter to continue using an earlier version of a consensus 
standard while preparing to use a newer version of the same consensus standard that may have 
significant changes.  By providing transition periods, FDA enables the submitter to continue 
current product development and testing potentially without having to conduct additional testing 
due to a newer version of a consensus standard having been published and recognized.  Due to the 
differences between standards, a justification for use of the older version of the standard should 
be provided when a newer version of the standard raises significant questions that were not 
previously addressed. 
A.  Where to Find Information on a Transition Period 
The transition period will be found within the SIS and will provide the name of the outgoing 
version of the consensus standard, the name of the newer version of the consensus standard, and 
the date the transition period expires.  The length of the transition period will be listed in the SIS 
at the time of recognition of the newer consensus standard.  An example of a transition period 
statement that will be included in the SIS for both standards is: 
 
FDA recognition of [the outgoing version of the consensus standard] will be 
superseded by recognition of [the newer version of the FDA-recognized consensus 
standard].  FDA will accept Declarations of Conformity, in support of premarket 
submissions, to [the outgoing version of the consensus standard] until [Month, 
Date, and Year]. After this transition period, Declarations of Conformity to [the 
outgoing version of the consensus standard] will not be accepted. 
B.  When Standards Change Prior to Review of a Premarket 
Submission 
FDA understands that standards may be updated or revised, and the newer version recognized, 
during product development.  This may present challenges to submitters.  FDA values and 
encourages early interaction with submitters to ensure scientific issues are addressed prior to the 
submission of a marketing application for a device, including a discussion of the changing 
standard.  The submitter is encouraged to engage the Agency regarding the strategy for addressing 
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the differences between the two versions of the standard and whether those differences 
significantly affect the evaluation of safety and effectiveness.  This is because it may not be 
necessary to comply with all parts of the revised standard, only those parts that significantly affect 
the evaluation of safety and effectiveness. 
C.  When Standards Change During Active Review of a 
Premarket Submission 
Generally, while a submission is undergoing active review, and in the interim before a consensus 
standard is updated or revised and recognized, FDA will continue to review that submission based 
on the previously FDA-recognized version.  If the updated or revised consensus standard 
addresses a new safety or effectiveness issue that is relevant to the final decision of that 
submission, FDA may ask the submitter to either meet the portions of the new or updated 
standard that address that safety or effectiveness issue, or provide alternative data or information 
along with a scientific rationale for why the alternative addresses the issue. 
D.  Transition Period Expiration 
FDA will withdraw recognition of an outdated consensus standard in accordance with section 
514(c)(2) of the FD&C Act at the end of a transition period.  Submitters should check the FDA 
Recognized Consensus Standards Database Web site often to ensure that their forthcoming 
premarket submissions utilize the appropriate version of a consensus standard.  If a submission is 
submitted to FDA after the transition period has expired, as noted in the SIS, FDA expects that 
testing will be completed using a standard with a current recognition number.  Statements 
declaring conformance to expired or earlier versions of the consensus standard will generally not 
be accepted.  It is expected that by the transition period expiration date, submitters will be able to 
meet the performance specifications of the newer version of the consensus standard.  
VI.  Promissory Statements 
For purposes of this guidance, a promissory statement is defined as a statement in which the 
submitter indicates that the device is not yet known to be in conformance with a consensus 
standard at the time of the premarket submission but will conform to the consensus standard prior 
to marketing.  FDA believes that in many cases the use of a promissory statement indicating 
future conformance with a consensus standard is not appropriate to support a premarket 
submission.  This is because many standards include general methods with multiple options, and 
in some cases, these standards do not include well-defined acceptance criteria or address 
assessment of results. Typically, if submitters rely on a consensus standard to support a premarket 
submission, FDA expects that conformance to the consensus standard will be met prior to 
submission of the application to FDA.  However, in some limited cases, a promissory statement 
may be acceptable to support a regulatory decision.  If it is determined that use of a promissory 
statement is appropriate, it should include a statement that the device will not be marketed until 
conformance has been confirmed.   
 
Although a promissory statement describes a situation where a submitter states that they will 
conform to a consensus standard that FDA has recognized or decided to recognize, submitters 
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may not use a DOC along with a promissory statement.  Under section 514(c) of the FD&C Act, 
submitters may only use a DOC to a consensus standard if conformance has been met prior to the 
submission of the application to FDA.  It is important to note that, in cases where FDA accepts 
promissory statements, manufacturers must still comply with the obligations under the quality 
system regulation in 21 CFR part 820, including design validation, 21 CFR 820.30(g), and 
process validation, 21 CFR 820.75(b), by which a manufacturer must also establish and maintain 
procedures for validating a device design and monitoring and control of process parameters for 
validated processes to ensure that the specified requirements continue to be met. 
 
VII. Limitations of Consensus Standards
 
A specific device may raise issues not addressed by consensus standards.  For example, 
submissions for some devices may rely on data from animal testing or clinical studies not 
addressed in consensus standards that FDA has recognized or decided to recognize.  In other 
instances, additional performance specifications may be applicable to the device that is the subject 
of the submission.  Additional information to support approval or clearance of a device may also 
be recommended in guidance documents.  When a submission contains a submitters DOC with 
one or more consensus standards, FDA reviews the premarket submission to ensure that the DOC 
is appropriate and that the premarket submission contains all of the other necessary information 
for FDA to evaluate the safety and effectiveness or, in the case of a 510(k), the substantial 
equivalence of the device. 
 
It is important to note that consensus standards with requirements and/or references to other 
normative requirements do not have precedence over existing FDA laws and regulations. 
VIII. When Devices or Standards Change After Marketing 
Authorization 
Just as standards may be revised before submission of an application to FDA, they may also be 
revised after marketing authorization is granted.  Changes in a recognized consensus standard do 
not retroactively affect a products clearance or approval status.  Furthermore, once a consensus 
standard is recognized, recognition of its revisions will not be automatic.  In general, FDA 
actively assesses the impact of new consensus standards and revisions of existing standards on the 
premarket review process and recognizes these standards, as appropriate.  As FDA determines 
that new or revised standards are appropriate for meeting requirements under the FD&C Act for 
medical devices, we will update the standards database on FDAs website.  As explained above, 
once we have decided to recognize a standard, we will issue a recognition number and provide 
supplemental information in the database.  To recognize such standards, we will periodically 
publish a recognition list in the Federal Register.  FDA usually performs this activity at least 
twice annually.  Superseded standards that FDA has withdrawn from the list of recognized 
standards cannot subsequently be used in DOCs.  
 
If a submitter received clearance or approval based in part on a DOC, but the standard is 
withdrawn from recognition, the cleared or approved device remains legally marketed and it 
remains eligible (for 510(k)s) as a predicate device.  However, any new device citing such a 
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predicate in a 510(k) submission cannot similarly rely on a DOC to the withdrawn standard.  In 
these circumstances, FDA will likely recommend that the submission use the newer version of the 
consensus standard, i.e., the version that has a current recognition number. 
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