Protocols for Conduct of Non-clinical
Testing, Report preparation &
Documentation
Guided by: Dr. Mrinalini Damle
Presented by: Prasad P. Amane, Yogita D. Bagul
(F. Y. M. Pharm)
INTRODUCTION
Protocols for Nonclinical testing information
Contents: Reporting of non-clinical testing
Documentation
Reference
Introduction:
• 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.
• 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, 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 animal or human tissue; and animal carcass or human
cadaveric testing.
Protocols for Nonclinical testing information:
• Each study shall have an approved written protocol that clearly indicates the objectives and all
methods:
o For the conduct of the study. The protocol shall contain, as applicable, the following information:
A descriptive title and statement of the purpose of the study.
Identification of the test and control articles by name, chemical abstract number, or code number.
The name of the sponsor and the name and address of the testing facility at which the study is being
conducted.
The number, body weight range, sex, source of supply, species, strain, sub-strain, and age of the test
system.
The procedure for identification of the test system.
Description of the experimental design, including the methods for the control of bias.
Cont.
Cont.
A description and/or identification of the diet used in the study as well as solvents, emulsifiers, and/
or other materials used to solubilize or suspend the test or control articles before mixing with the
carrier. The description shall include specifications for acceptable levels of contaminants that are
reasonably expected to be present in the dietary materials and are known to be capable of
interfering with the purpose or conduct of the study if present at levels greater than established by
the specifications.
Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units,
of the test or control article to be administered and the method and frequency of administration.
The type and frequency of tests, analyses, and measurements to be made.
The records to be maintained.
The date of approval of the protocol by the sponsor and the dated signature of the study director.
A statement of the proposed statistical methods to be used.
• All changes in or revisions of an approved protocol and the reasons therefore shall be
documented, signed by the study director, dated, and maintained with the protocol.
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Reporting of non-clinical testing
• To facilitate FDA’s review, FDA recommend that in all premarket submissions containing nonclinical 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.
• When necessary, you should provide complete test reports as separate attachments to the premarket submission.
• You can provide test protocols as separate attachments to the premarket submission, or as part of a complete test
report.
• The submitted summaries, test protocols, and test reports should be clear, legible, and written in English or have
English translations.
• It should contain:
A. Test report summaries.
B. Complete Test Reports.
A. Test report summaries:
FDA recommend that you should provide test report summaries that briefly describe and summarize
the testing performed to support the submission.
It should include:
1. Test(s) performed
2. Objective(s) of the test(s)
3. A brief description of the test methods, including sample size, device(s) tested, and any consensus
standard(s) utilized
4. Pre-defined pass/fail criteria (when applicable)
5. Results summary
6. Conclusions
7. Location of complete test report
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1. Test(s) performed:
o You should identify the tests performed.
o If the testing was conducted as recommended by a FDA guidance document, FDA recommend that you
state such in the test report summary.
2. Objective(s) of the test(s):
o 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 :
o you should briefly describe the test methods used for the conducted bench tests, or reference.
o You should also provide a description of the test sample that was tested, whether that sample is the
entire device.
o you should include a brief discussion on sample selection.
4. Pre-defined pass/fail criteria:
o your test report summary include an identification of the acceptance criteria.
o 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.
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Cont.
5. Results summary:
o Provide an appropriate summary of data (in tabular and/or text format), including a summary from any
analyses performed.
o Specify whether the acceptance criteria (if applicable) were met.
o Provide a brief explanation of study results that do not meet acceptance criteria
6. Conclusions:
o Your test report summaries should provide a discussion of the conclusions drawn from the test results.
o This section of the test report summary can be used to provide additional information regarding the testing
conducted and/or observed test results
7. Location of complete test report:
o 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.
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B. Complete Test Report:
• FDA recommends 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.
• Complete test reports should include the information described below:
1. Test performed
2. Objective of the test
3. Description of test methods
4. Pass/Fail criteria
5. Data analysis plan
6. Test results
7. Discussion/Conclusions
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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.
• It should include:test sample information, test sample size/selection, test methods.
4. Pass/fail criteria:
• You should describe in the test report, the acceptance criteria.
• Including specifications or acceptance and rejection criteria, and a clinical/scientific/engineering
justification for these criteria, when applicable.
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Cont.
5. Data analysis plan:
o FDA recommend that your test report include the data analysis plan used to analyze your results.
o Your data analysis plan should include all planned quantitative and/or qualitative assessments.
6. Test results:
o FDA recommend that you include the following items in the test results section of your test report:
I. Data.
II. Data analysis.
III. Protocol deviations.
7. Discussion/Conclusions:
o FDA recommend that the test report discuss the conclusions drawn from the test results in
consideration of the stated study objective.
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Documentation:
• Storage and retrieval of records and data:
• All raw data, documentation, protocols, final reports generated as a result of a nonclinical
laboratory study shall be retained.
• There shall be archives for orderly storage and expedient retrieval of all raw data,
documentation, protocols, specimens, and interim and final reports.
• An individual shall be identified as responsible for the archives.
• Only authorized personnel shall enter the archives.
• Material retained or referred to in the archives shall be indexed to permit expedient
retrieval.
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Retention of records:
o The record retention should specify that the retention period for records related to
nonclinical laboratory studies.
•At least 2 years after the approval date of a research or marketing permit application, unless it
pertains to Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications
(which have different requirements).
•At least 5 years after the submission of study results to the FDA in support of a research or marketing
permit.
•At least 2 years after the completion, termination, or discontinuation of a nonclinical study if no
permit application is involved.
o Materials like fragile specimens, samples, and test materials should only be retained as long
as their quality supports evaluation, and no retention period should exceed.
• Additional requirements include:
• The quality assurance unit must maintain master schedules, protocols, and inspection records.
• Employment records, training summaries, and job descriptions
• Equipment maintenance, calibration, and inspection records.
• Records can be kept as original or accurate copies (e.g., photocopies or microfilm).
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Reference:
1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket
2. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58/subpart-G
3. https://www.ecfr.gov/current/title-21/part-58/subpart-J
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Thank you
