What You Need to Know about FDA’s Draft Guidance on Writing Test Reports

For Kapstone Medical

The FDA issued updated draft guidance for submission of test reports and non-clinical bench test performance in premarket submissions in May 2018. As a draft guidance, the FDA is seeking comment from the industry prior to finalization. (published site)

The purpose of the guidance is to describe the relevant information that should be included in complete test reports for non-clinical testing, which encompasses all bench testing and the specifics of the actual device or device type. By non-clinical, the FDA specifies mechanical engineering performance, including tensile strength, compression, fatigue, wear, and burst pressure. Bench tests using animals, human tissues, or cadavers are included.

Complete test reports are NOT required for 510(k) submissions or for tests for which a Declaration of Conformity to an FDA-recognized consensus standard is provided.

The Test Report Draft Guidance specifies that a test report should include six sections:

• Test description
• Test objective
• Methods and procedures used
• Predefined pass/fail criteria
• Results
• Discussion and conclusions

Within the first section, the draft guidance recommends a summary report that briefly describes the tests performed, objectives of the test and brief description of the methods/procedures, sample size, and standards used.

The first two sections should clearly and completely describe the test performed and the objective of the test. This should include the sample that is tested, whether the device itself or a part of the device, or an attribute is the object of the test. Tested devices should represent the final, finished device that has been produced through all manufacturing processes to be used for production. These include sterilization, environmental conditioning, and simulated transportation.

If the test report is about non-final or unfinished products, clearly indicate this in the test protocol and test summary table, along with justification for this submission.

The third section summarizing methods and procedures should include the scientific rationale for the samples tested including the sample size, which should support substantial equivalence assessment, and risk assessment along with the sampling plan. If a represented model is used for all models included in your submission, you need to justify how the test model represents the respective design tested. You also need to account for inter- and intra-lot variability among multiple manufacturing lots when appropriate.

In addition, the methods section needs to contain enough detail about the test protocol that someone familiar with testing of the device type can interpret the purpose and method of testing and whether the test setup was appropriate to assess the performance of this device type. NOTE: if FDA-recognized consensus standards were used for testing, the test protocol description is not needed.

Section 4, the predefined pass/fail criteria description, should include the acceptance criteria and clinical or scientific justification for the pass/fail parameters based on the clinical requirements of the device.

The test results section needs to include all the data points collected where appropriate along with a summary of the data including minimum, maximum, average and standard deviation. The data analysis should include any outlying points or anomalous results. Data analyses should use accepted statistical methods when appropriate and explain whether acceptance criteria were met. You should also describe any protocol deviation that occurred and the effect it might have had on the test results.

The discussion and conclusions section should thoroughly describe the conclusions drawn from the test and the clinical significance of the conclusions. For 510(k) submissions, the conclusions should demonstrate substantial equivalence of your device to the identified primary device based on technical characteristics, known clinical performance, and the relevance to the intended use of the device.

Whatever regulatory process you need to navigate, Kapstone Medical has the experience and expertise to assist you through all phases of the process. For more information contact us today at (704) 843-7852 or by email at info@kapstonemedical.com.