The Food and Drug Administration (FDA), the US medical device regulating agency, issues detailed guidance on format and content of testing information to be provided in the course of premarket application submission.
The Scope of the Guidance
The guidance is dedicated to information on testing procedures that should be provided by the applicant as a part of the premarket approval application (PMA). It also covers other types of applications that could be filed to the FDA regarding medical devices being placed on the market, including basic 510(k) applications and DeNovo requests (special application form used for a device that has no analogs already registered with the agency). The scope of the guidance covers test protocols and report summaries. The document is intended to assist medical device manufacturers in preparing the documentation on non-clinical bench performance testing included in the premarketing application. At the same time, due to the legal nature of the guidance as a document, all information provided constitutes recommendations rather than obligatory requirements and the agency reserves the right to implement new rules and request additional documents.
The guidance provides the definition of non-clinical bench performance testing as performance testing that could be conducted by the manufacturer of the medical device itself or via the involvement of an independent third party. The scope of topics covered by such testing depends on the particular device subject to review and its specific features but still includes all bench testing.
Non-clinical bench performance testing includes, among others, the following types:
– Mechanical and biological performance,
– Bench testing conducted with ex vivo, in situ, and in vitro approaches.
However, it does not include the following testing types:
– Validation of sterilization,
– Verification of software,
– Evaluation of biocompatibility,
– Computer-based modeling,
– Evaluation of human factors,
– Any testing conducted to assess an In Vitro Diagnostic (IVD) medical device.
Requirements of Format And Content of The Information Provided
According to the guidance, it is advised to include both complete test reports and test report summaries into the dossier if it is required due to the submission type. Depending on the particular situation, test report summaries could be either included in the application itself or provided separately as an independent document. Both these approaches are also applicable to complete test reports. All information should be provided in a clear and structured manner in English or accompanied by a translation in English if it is primarily being provided in another language.
The agency also notices that it is not necessary to provide the complete test report in Special 510(k) submissions and for Abbreviated 510(k) submissions. In general, such information is used to provide confirmation of substantial equivalence for general 510(k) submissions. In the case of an application that has no references to the predicate (similar device already present at the market), for example, in the case of PMA or DeNovo submissions, test information would be used to confirm the safety and effectiveness of the device as claimed by the manufacturer. The requirement on the complete test report submission may also vary depending on the scope of documents accompanying the Declaration of Conformity if it is provided.
Types of Reports And Applicable Requirements
The guidance also provides detailed requirements for each type of information that can be submitted to the FDA.
- Test report summaries – short description and summary of testing results conducted prior to the submission. The document should contain the following information:
- Description of tests performed with references to the guidance or standard used when applicable.
- The objective of the test if a complete test report is not added to the documents submitted.
- Description of testing methods used, as well as details on device samples subject to testing with references to the appropriate consensus standards when applicable.
- Pre-defined criteria used to evaluate testing results.
- Summary of the results, including the parameters for quantitative assessment and the characteristics of qualitative data. The summary should also indicate whether the pre-defined criteria had been met, as well as an additional description if it had not been met.
- The discussion of a summary containing supplementary information on tests performed and their results. This part of the report contains all additional data that is necessary to assess the report that does not fit in other categories. For example, it could include the justification of methods used unless the use of such methods is prescribed by the applicable standard recognized by the FDA. Is should also describe the connection between testing results and the intended purpose specified by the manufacturer.
- Reference to the test report providing links between each summary and respective test report.
- Summaries in the form of a table as an alternative form of presentation.
- Complete test report – the whole scope of information related to testing, either as a separate document or as a group of documents. The agency additionally emphasizes that it could be necessary to provide originals for any of the documents initially provided to the agency as a scanned copy. The complete test report should contain the following elements:
- Description of tests performed.
- The objectives of testing (that could be also included in the protocol of testing).
- Description of testing methods utilized in a clear manner and detailed enough for the specialist in the appropriate sphere to be able to evaluate whether the testing complies with applicable requirements. This ensures the accuracy and reliability of the results obtained. If any of the consensus standards recognized by the FDA are used, it is also necessary to describe the particular way it has been applied. This section should also include information on the medical device sample used for testing, the number of samples and also the reasoning for choosing such a number. According to the general rule, the device subject to testing should be equal to the device that would be placed on the market, i.e. it should be the final version of the device. The description should also cover the information on the testing methods used.
- Criteria used to evaluate testing results.
- Data analysis plan describing the approach utilized to analyze the report data.
- The results of testing including data, its analysis and the description of deviations found if applicable.
- Discussions as the general section containing all additional information.
- Test protocol – an additional document containing information on testing objectives, description of utilized methods, the indication of pre-defined criteria used to evaluate the results and also the data analysis plan. According to the positions of the agency, the aforementioned information could be either composed into test protocol as a separate document or provided in the complete test report.
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