Your Roadmap for Premarket Submissions
Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.
The revised guidance provides recommendations for 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).
Non-clinical bench performance testing
Non-clinical bench performance testing is defined as performance testing, performed by either a device manufacturer or a third party testing facility (e.g. a 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 performance (such as fatigue, wear, tensile strength, compression, burst pressure),
- Bench tests using ex vivo, in vitro, and in situ animal or human tissue; and animal carcass or human cadaveric testing.
However, it does not include the following types of testing:
- Biocompatibility evaluation,
- Reprocessing or sterilization validation,
- Human factors,
- Software verification and validation,
- Computational modeling.
Test reports for clinical studies, animal studies, and studies evaluating the performance characteristics of in vitro diagnostic devices are also excluded.
Test report summaries
Each premarket submission requires that appropriate and complete testing be presented in a report so the FDA can effectively evaluate the safety and efficacy of the device. It is in the best interest of the device submitter to provide the FDA reviewers with a complete, clear and concise submission so that they do not have to sift through descriptive test reports to find the review-related information. Providing a clear and complete test report increase the submitter’s chances of a shorter review period and successful approval.
The FDA recommends including test report summaries within the body of a submitter’s premarket submission that briefly describe and summarize:
- Test performed
- Test methods
- Pre-defined pass/fail criteria (when applicable)
- Results summary
- Location of the complete test report
- Summary table (optional)
An example of a summary table format from the guidance is shown below:
|Test Performed||Test title, document number, location in file|
|Device Description/Sample Size||Test/control article identification, sample size|
|Test Method/Applicable Standards||Brief summary of test method, preconditioning, standard(s) used|
|Acceptance Criteria||Include clinical/scientific/ engineering justification|
|Unexpected Results/Significant Deviations||Report any unexpected results or significant deviations with an explanation of how they do not affect the overall conclusion|
Min, max, average
However, if a summary table is used, the guidance recommends that a narrative discussion of the results/conclusions is still provided within the submission.
Complete test reports
As for the complete test report(s), the guidance calls for it to be attached to the main body of the submission, such as in an appendix. A complete test report would contain all of the testing documentation submitted for a study, presented either in a single document, or in multiple, separate documents.
The complete test report would include information such as:
- Description of methods (including protocols, test parameters, equipment used, and conditions);
- Assessment criteria;
- Test sample size/selection;
- Data analysis plan; and
- Protocol deviations, if any.
There are situations where pre-defined pass/fail criteria may not be applicable, such as tests conducted for characterization purposes. In these situations, provide a description of the acceptance criteria used to allow for interpretation of the data.
While the guidance does provide a comprehensive list of information to include within the complete test reports, some information that is required for verification and validation results by the Quality System Regulation (QSR) (e.g. the date, and the individual(s) performing the tests) is missing.
Additionally, the guidance recommends that test reports state whether the test sample is a final, finished device, though this may not be known at the time since test reports are often written during product development. A final, finished device is one that has been subjected to all the manufacturing processes (including simulated transportation, environmental conditioning, sterilization, etc.) of the ‘to be marketed’ device.
Each device submitter should approach their non-clinical bench performance testing strategy with a master test plan, so that all known tests can be identified and budgeted. Manufacturers are encouraged to discuss their test strategy with the FDA prior to starting any testing, via a pre-submission meeting. Pre-submission meetings are highly recommended in order to avoid potential issues with the device submission and data package.
This is especially important if any testing is unique to your device and not covered under any known performance standard, whether it is an FDA recognized consensus standard or not. However, these meetings are limited only to the FDA review of the test protocols, and not the test results or the interpretation of the test results.
Providing test reports with well-organized, non-clinical bench performance testing data supporting the safety and efficacy of your device will move your premarket submission through the FDA’s review process with fewer questions and an increased likelihood of a successful approval.
Alexandra (Sandy) Reid is a StarFish Medical QA/RA specialist. She brings years of experience working in the industry, including with StarFish where she supported our Business Development team.