Contains Nonbinding Recommendations 
Recommended Content and Format of 
Non-Clinical Bench Performance 
Testing Information in Premarket 
Submissions 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on December 20, 2019. 
Document originally issued on April 26, 2019. 
For questions about this document regarding CDRH-regulated devices, contact the Regulatory 
Advisors at RPG@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, or by email at ocod@fda.hhs.gov. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research 
1  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-2018-D-1329. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
18011 and complete title of the guidance in the request. 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics. 
2 Contains Nonbinding Recommendations 
Recommended Content and Format of 
Non-Clinical Bench Performance 
Testing Information in Premarket 
Submissions 
______________________________________________________________________________ 
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 and Scope 
The Food and Drug Administration (FDA) has developed this document to describe relevant 
information that should be included in test report summaries, test protocols, and complete test 
reports for non-clinical bench performance testing provided in a premarket submission (i.e., 
premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, 
premarket notification (510(k)) submissions, investigational device exemption (IDE) 
applications, and De Novo requests). 
For the purpose of this document, non-clinical bench performance testing is defined as 
performance testing, performed by either a device manufacturer or a third party testing facility 
(e.g., test laboratory), which encompasses all bench testing and will be dependent upon the 
specifics of the actual device or device type. Non-clinical bench performance testing includes, 
but is not limited to: mechanical and biological engineering performance (such as fatigue, wear, 
tensile strength, compression, and burst pressure); bench tests using ex vivo, in vitro, and in situ 
animal1 or human tissue; and animal carcass or human cadaveric testing. 
                                                
1 FDA supports the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage sponsors to consult with us if it they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency 
to an animal test method. 
3 Contains Nonbinding Recommendations 
Non-clinical bench performance testing excludes biocompatibility evaluation, reprocessing or 
sterilization validation, human factors, software verification and validation, and computational 
modeling, because relevant information on these assessments are detailed in associated guidance 
documents. Test reports for clinical studies, animal studies, and studies evaluating the 
performance characteristics of in vitro diagnostic devices are also excluded from the scope of 
this document. 
The information listed below is intended to help ensure that clear and consistent information is 
provided in premarket submissions containing non-clinical bench performance testing.2 The 
information in this guidance is intended to be used in conjunction with other FDA guidance 
documents, including device-specific guidances, as well as in conjuction with specific test 
reporting recommendations in FDA-recognized standards. For more information regarding use of 
consensus standards in regulatory submissions, please refer to the FDA guidance titled 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices3 and Standards Development and the Use of Standards in Regulatory Submissions 
Reviewed in the Center for Biologics Evaluation and Research.4
FDA's 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.  Reporting of NonClinical Bench Performance Testing 
Information
To facilitate FDAs review, we recommend that in all premarket submissions containing non-
clinical bench performance testing information, you include test report summaries (i.e., a 
summary of the conducted testing as described by the submitter of the premarket submission) 
and complete test reports, when appropriate. You should provide test report summaries either 
embedded within an executive summary section of the premarket submission or provided as a 
separate document within the premarket submission (see Section II.A for more details). When 
necessary, you should provide complete test reports as separate attachments to the premarket 
submission (see Section II.B for more details). You can provide test protocols as separate 
attachments to the premarket submission, or as part of a complete test report (see Section II.B 
                                                
2 The recommendations in this guidance are consistent with the least burdensome provisions (see Sections 513(a), 
513(i), and 515(c) of the Federal Food, Drug, and Cosmetic Act) and guiding principles described in the guidance 
The Least Burdensome Provisions: Concept and Principles available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles. 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-
and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation. 
4 Contains Nonbinding Recommendations 
and C for more details). The submitted summaries, test protocols, and test reports should be 
clear, legible, and written in English or have English translations. 
Complete test reports are typically not needed for Special 510(k)s and for some testing provided 
within Abbreviated 510(k)s. For premarket submissions with tests for which a Declaration of 
Conformity (DOC) to an appropriate FDA-recognized consensus standard is provided, the 
information to support the DOC (i.e., supplemental documentation) will vary based on the 
elements addressed by the consensus standard, but may include test report summaries, test 
protocols, and/or complete test reports. For additional information regarding the use of consensus 
standards and a DOC, please refer to the FDA guidance titled Appropriate Use of Voluntary 
Consensus Standards in Premarket Submissions for Medical Devices5 and Standards 
Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for 
Biologics Evaluation and Research.6
Your premarket submission should also discuss how the non-clinical bench performance test 
results support the overall submission (e.g., substantial equivalence for 510(k), reasonable 
assurance of safety and effectiveness for PMA). The conclusions from your testing should 
discuss, for example, how the testing demonstrates substantial equivalence of your device to the 
identified primary predicate device for a 510(k)7 or demonstrates a reasonable assurance of 
safety and effectiveness of the device for a PMA8 or De Novo request.9 This information can be 
provided in the test report summary (see Section II.A below) or another location in your 
premarket submission, and the information should be referenced appropriately for ease of 
identification within the submission. 
A.   Test Report Summaries 
We recommend that within the body of your premarket submission, you provide test 
report summaries that briefly describe and summarize the testing performed to support 
the submission. The test report summaries may be included within the executive 
summary of a premarket submission. Alternatively, a test report summary may be 
provided as a distinct document within the premarket submission (e.g., as a preface to the 
complete test reports). The test report summaries should include the following elements: 
                                                
5 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
6 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-
and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation. 
7 See FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] 
- Guidance for Industry and Food and Drug Administration Staff, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-
notifications-510k. 
8 See 21 CFR 814.20. 
9 See FDA Guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance 
for Industry and Food and Drug Administration Staff, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-
designation. 
5 Contains Nonbinding Recommendations 
1.  Test(s) performed 
You should identify the tests performed. If the testing was conducted as 
recommended by a FDA guidance document or FDA-recognized consensus standard, 
we recommend that you state such in the test report summary. 
2.  Objective(s) of the test(s) 
You should provide test objectives in the test report summary if a complete test report 
is not provided within the premarket submission. 
3.  A brief description of the test methods, including sample size, 
device(s) tested, and any consensus standard(s) utilized 
In the test report summary, you should briefly describe the test methods used for the 
conducted bench tests, or reference an established method that was followed, such as 
any FDA-recognized consensus standards that were used for the conducted testing.  
You should also provide a description of the test sample that was tested (whether it is 
a final, finished device or not), and whether that sample is the entire device, a part or 
component, or an attribute of the device (e.g., the devices material 
composition/properties or packaging). In addition to the description of the test 
sample, you should include a brief discussion on sample selection (e.g., size or 
configuration) and how the samples represented a clinically relevant worst-case 
scenario(s).  
4.  Pre-defined pass/fail criteria (when applicable) 
We recommend that your test report summary include an identification of the 
acceptance criteria, when applicable, that were pre-defined and that were applied 
during testing. When a non-clinical bench performance test that is conducted for 
characterization purposes does not have acceptance criteria, you should still provide a 
description of the assessment criteria that you used to allow for interpretation of the 
data, for example, the visual inspection criteria utilized for coating integrity testing 
when assessing voids or cracks. 
5.  Results summary 
a. Provide an appropriate summary of data (in tabular and/or text format), 
including a summary from any analyses performed. For example: 
  For quantitative assessments, provide appropriate summary 
parameters such as: the mean, standard deviation, minimum, and 
maximum for normal data; or summary parameters per the data 
analysis plan. 
  For attribute or qualitative data, provide an appropriate summary 
of the number of observed characteristics by category (e.g., 
6 Contains Nonbinding Recommendations 
characteristic present/total observations, characteristic absent/total 
observations). Include statistical information such as 
confidence/reliability level, if applicable. 
b.  Specify whether the acceptance criteria (if applicable) were met. 
c.  Provide a brief explanation of study results that do not meet acceptance 
criteria, and/or protocol deviations that may have impacted the study results, 
conclusions, or data integrity, and describe how the resulting concerns were 
resolved. 
6.  Discussion/Conclusions 
Your test report summaries should provide a discussion of the conclusions drawn 
from the test results. This section of the test report summary can be used to provide 
additional information regarding the testing conducted and/or observed test results 
(e.g., justification for the methods used to perform the testing, clinical/scientific/  
engineering basis for the acceptance criteria, outlying and anomalous results). Note 
that a justification for methods and/or acceptance criteria is generally not needed if 
they were directly obtained from a FDA-recognized consensus standard or guidance 
document. A discussion of the test methods or acceptance criteria, if needed, can 
include how the testing relates to the use of the device in clinical practice or as 
described in literature. For example, tracking tests typically use a fixture that 
simulates the target anatomy. A discussion or justification for the tracking test fixture 
used would address how the testing relates to expected worst-case clinical use for the 
indicated anatomical location. For non-clinical bench performance tests that are 
conducted for characterization purposes, the conclusions should address the 
relationship between the results and the intended performance of the device. As noted 
above, a brief discussion of how the test results support the overall submission can be 
included in the test report summary or another location in your submission. 
7.  Location of complete test report 
We recommend that you identify the location (e.g., appendix and/or page number) for 
each complete test report for which a summary is provided, if applicable.  
8.  Summary table (optional) 
As an alternative to a written narrative for each non-clinical bench performance test, a 
tabulated summary can be provided to organize the information recommended in a 
test report summary (see below for example). If a summary table is used, it is still 
recommended that a narrative discussion of the results/conclusions be provided as 
described above in Section II.A.6, when needed. 
7 Contains Nonbinding Recommendations 
Test  Device  Test  Acceptance  Unexpected  Results 
Performed  Description/Sample  Method/Applicable  Criteria  Results/Significant 
Size  Standards  Deviations 
Test title,  Test/control article  Brief summary of  Include  Report any  Pass/Fail 
document  identification,  test method,  clinical/scientific/  unexpected results 
number,  sample size  preconditioning,  engineering  or significant  Or 
location in  standard(s) used  justification  deviations with an 
Min, 
file  explanation of how 
max, 
they do not affect 
average 
the overall 
conclusion 
B.  Complete Test Reports 
We recommend that premarket submissions include complete test reports attached to the 
main body of the submission (e.g., in an appendix). A complete test report means the 
entirety of the testing documentation submitted for a study, which some submitters or test 
labs might embody in a single document, while others might embody in multiple and 
separate documents (e.g., a test protocol and a test report; see Section II.C). We 
recommend that efforts be made to ensure that scanned test reports are legible in order to 
reduce the likelihood of requests for additional, more legible, copies.10
Complete test reports should include the information described below.  
1.  Test performed 
The test report should clearly state the test that was performed. 
2.  Objective of the test 
The test report should state the purpose of the test that was conducted.  Note that this 
information can alternatively be provided in the test protocol. 
3.  Description of test methods 
You should provide a detailed description of the test methods with sufficient detail 
that an individual familiar with testing of the device type will be able to interpret the 
purpose of the test, how the test was conducted, and whether the test setup and data 
analysis was appropriate to assess the performance of the device type. 
If FDA-recognized consensus standards that include test methods are utilized during 
testing, providing detailed test methods or a test protocol is generally unnecessary, 
                                                
10 See FDA Guidance eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug 
Administration Staff, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/ecopy-program-medical-device-submissions. 
8 Contains Nonbinding Recommendations 
even when a DOC to the standard is not provided (i.e., general use of consensus 
standards). Instead, you should provide a full citation of the standard, including the 
version, and information regarding the extent to which the standard was followed, 
including deviations from the standard. Similarly, if you provide a DOC to a FDA-
recognized consensus standard that includes test methods, providing detailed test 
methods or a test protocol is typically not necessary. When the FDA-recognized 
consensus standard includes choices related to, for example, what is to be tested, 
which test methods to use, or performance limits to assess conformity, you should 
include an explanation for the choices and selections made. When test methods have 
deviated from the FDA-recognized consensus standard used, we recommend that you 
provide this information within the DOC if one is submitted, or within the complete 
test report if no DOC is submitted. For additional information regarding the use of 
consensus standards, DOC, and supplemental documentation to support a DOC, 
please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus 
Standards in Premarket Submissions for Medical Devices11 and Standards 
Development and the Use of Standards in Regulatory Submissions Reviewed in the 
Center for Biologics Evaluation and Research.12    
a.  Test sample information 
The test report should provide a description of the test sample that was tested 
(whether it is a final, finished device or not), and whether that sample is the entire 
device, a part or component, or an attribute of the device (e.g., the devices 
material composition/properties or packaging). 
Generally, the tested devices should represent the final, finished device that has 
been subject to all manufacturing processes for the to be marketed device 
(including sterilization, environmental conditioning, simulated transportation, 
etc.). If you conducted any testing on samples that are not the final, finished (e.g., 
sterilized) product or part or component, we recommend that you indicate this in 
the test report summary and the test report, if known (e.g., if test lab is aware that 
the test sample is not the final, finished device), along with a justification 
explaining why this approach is appropriate given any differences that may 
impact performance of the tested device compared to the final, finished device 
that is to be marketed. You should specify the number of sterilization cycles or 
other conditioning (e.g., simulated use, environmental conditioning, distribution 
simulation, aging) that the samples have been exposed to prior to testing. If test 
samples were conditioned or sterilized in a manner that is different than what is 
intended for the marketed product, we recommend that you provide a 
justification. 
b.  Test sample size/selection 
                                                
11 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
12 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-
and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation. 
9 Contains Nonbinding Recommendations 
We recommend that you provide a scientific rationale to support the number of 
samples tested. The sample size selected should be based upon the objective of 
the study and supported by your risk analysis and sampling plan. For testing 
performed according to a FDA-recognized consensus standard or as specified in a 
FDA guidance document, the sample size selected should meet the applicable 
recommendations of the standard or guidance. When applicable, you should 
follow any device-specific guidance document recommendations for sample 
selection. 
If one particular device model is used to represent the entire family (or a subset 
thereof) of device models included in your submission, you should justify why the 
tested device is representative of the entire product family (or subset) and explain 
why the tested device represents the worst-case design for that respective test. In 
some cases, there may be multiple worst-case designs per family, and a four-
corners or bracketed approach may be appropriate and should be justified. 
Finally, your test sample selection should account for both inter- and intra-lot 
variability by examining multiple manufacturing lots, when appropriate (e.g., 
when it is expected that such sampling is likely to impact the testing results and/or 
is needed to adequately capture the variability in the testing results). 
c.  Test methods 
The test report should contain a concise description of the test methods utilized in 
the conducted testing. You should also include materials used, methods, and a 
description of the test parameters, including an explanation of and rationale for 
critical test parameters, when appropriate, and any specific sample preparation 
steps. In many cases, labeled diagrams or photographs of the test setup and test 
fixtures can be helpful in understanding the test methods, and should be included 
with the test methods to provide appropriate context. 
4.  Pass/Fail criteria 
You should describe in the test report, the acceptance criteria that you prospectively 
identified, including specifications or acceptance and rejection criteria, and a 
clinical/scientific/engineering justification for these criteria, when applicable. The 
acceptance criteria should be based on the specific performance needs of the device and 
the intended use of the device. An example of an appropriate clinical/scientific/ 
engineering justification for an acceptance criterion includes a performance specification 
of the device based on clinical use; e.g., tensile strength of component should be 10 
times the expected normal working load since failure of the component could cause 
serious injury to patients. If applicable, you should refer to FDA-recognized consensus 
standards or FDA guidance documents for recommended acceptance criteria. When a 
non-clinical bench performance test that is conducted for characterization purposes does 
not have acceptance criteria, you should still provide a description of the assessment 
10 Contains Nonbinding Recommendations 
criteria that you used to allow for interpretation of the data, at a minimum, in the test 
report summary. 
5.  Data analysis plan 
We recommend that your test report include the data analysis plan used to analyze your 
results. Your data analysis plan should include all planned quantitative and/or qualitative 
assessments. 
6.  Test results 
We recommend that you include the following items in the test results section of your test 
report: 
a.  Data 
We recommend that you present the data collected for all test samples (including 
outlying and anomalous results) during the tests conducted to support the 
premarket submission, where appropriate and routinely provided. The results 
should be presented in data sheets or tables. These data should be accompanied by 
a summary of the data and applicable statistical information. Also, in situations 
where they may yield additional context, such as when testing to failure, images 
of the failure mode should be provided. You should use appropriate units of 
measure that are consistent throughout your report. Values should be reported to 
the appropriate significant digit, and if the data is rounded, you should specify the 
rounding method used. 
b.  Data analysis 
You should analyze the data, including any outlying points and anomalous results, 
using statistical analyses when appropriate, and indicate whether the acceptance 
criteria were met. As discussed in Section II.A.5, these analyses could include 
quantitative and/or qualitative assessments. If the data analysis concludes that the 
acceptance criteria were not met for either individual samples or entire sample 
populations, we recommend that you discuss (in either the test report or test report 
summary) the potential reasons for failure of the testing to meet the acceptance 
criteria, and whether re-testing was determined to be appropriate and why. 
c.  Protocol deviations 
We recommend that you describe test protocol deviations, particularly those that 
may have impacted the study results, conclusions, or data integrity. The test report 
should discuss the reasons why the deviations occurred, a description of any 
activities executed to determine the source of the deviation, and an assessment of 
their impact on the test results, conclusions, or data integrity. 
11 Contains Nonbinding Recommendations 
7.  Discussion/Conclusions 
We recommend that the test report discuss the conclusions drawn from the test 
results in consideration of the stated study objective. For example, the test report 
conclusions should indicate whether the pre-specified acceptance criteria were 
met. 
C.  Test Protocols 
A test protocol typically consists of the methods that were used to conduct the testing 
(see Section II.B.3), the objective of the test (see Section II.B.2), pre-specified acceptance 
criteria (see Section II.B.4), and data analysis plan (see Section II.B.5). This information 
can be provided in the premarket submission within the complete test report, or can be 
provided as a separate test protocol document submitted along with the test report. 
12