The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document providing recommendations on the content and format of non-clinical bench performance testing information in the context of premarket submission. The document does not introduce any requirements itself but provides additional recommendations and clarifications to be considered by the parties involved. The Agency also states that an alternative approach could be applied, provided such an approach complies with the existing regulatory requirements and is approved by the authority in advance. The initial version of the document was issued by the authority earlier in April 2016.
Regulatory Background
The present FDA guidance is intended to provide medical device manufacturers and other parties involved with additional clarifications on the information to be submitted in test report summaries and protocols related to non-clinical bench performance testing.
The approach described in the document could be applied in the context of the following frameworks:
- Premarket approval (PMA) applications,
- Humanitarian device exemption (HDE) applications,
- Premarket notification (510(k)) submissions,
- Investigational device exemption (IDE) applications, and
- De Novo requests (special requests to be submitted with regard to entirely new medical devices having no similar products already placed on the market).
The non-clinical bench performance testing addressed in the document refers to 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 animal or human tissue; and animal carcass or human cadaveric testing.
The authority additionally mentions that it encourages reducing animal use in testing to the lowest extent possible. However, the non-animal testing methods should be discussed with the authority in advance in order to determine their equivalency to the appropriate animal test method.
It is also important to mention that the scope of non-clinical bench performance testing does not cover such aspects as:
- Biocompatibility evaluation,
- Verification and validation of software,
- Validation of sterilization or reprocessing procedures, and some others.
The aforementioned matters are addressed in separate guidance documents issued by the FDA. The scope of the present guidance also does not cover the testing related to performance characteristics of in vitro diagnostic medical devices.
The FDA guidance on non-clinical bench performance testing information is intended to provide interested parties with additional clarifications on the particular information to be included in the scope of a premarket submission.
Non-Clinical Bench Performance Testing Information: Reporting
In order to simplify and streamline the submission review process conducted by the regulating authority, the latter encourages the applicants to submit “test report summaries,” which are summaries of the testing conducted, and “complete test reports” containing all the information.
Test report summaries could be provided:
- Separately as one of the documents included in a submission, or
- Together with an executive summary of a submission.
In certain cases, it is also necessary to provide complete test reports. Test protocols could be provided as separate documents or included in complete test reports.
All the documents mentioned above should be provided in English or accompanied with the translation in English if initially issued in another language.
The applicable requirements will depend on the type of the submission, such as Special 510(k) or Abbreviated 510(k). Test reports could also be submitted in support of a Declaration of Conformity, together with references to the applicable FDA-recognised voluntary consensus standards. The applicant shall also justify the way the test results provided correspond with the submission in general. For instance, they could be used to demonstrate substantial equivalence with the predicate – a similar medical device already placed on the market. Additionally, they could be used to provide details about the safety and performance of a medical device subject to review. The Agency recommends adding references to simplify navigation among the documents included in the submission.
Test Report Summaries
The Agency encourages the applicants to include test report summaries in the submission itself. Such a summary shall provide an overview of the testing carried out to collect additional data necessary to justify the claims made in the submission. However, as mentioned, a test report summary could also be provided as a separate document.
According to the present FDA guidance, a test report summary shall contain the following:
1. Description of the tests conducted. Should they be based on a guidance or standard, the appropriate reference should be provided.
2. Test objectives. If a complete test report is not included in the scope of the documents submitted, the objectives of testing should be specified separately.
3. Description of testing methods. The Agency also expects the applicant to provide an overview of the testing methods used. Such a description should cover such aspects as the sample size, device(s) tested, and any consensus standard(s) utilized… and 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. The document submitted shall also contain information about the pre-defined pass/fail criteria used in the course of non-clinical bench performance testing described therein. If this is not applicable, at least the information about the assessment criteria should be provided.
5. Results summary. The document shall provide a summary of parameters (e.g., standard deviation) or of the number of observed characteristics by category. It is also important to indicate whether the acceptance criteria have been met and provide an explanation if not.
6. Conclusions. The authority also asks to provide a discussion of the conclusions based on the results obtained in the course of non-clinical bench performance testing. All additional information could also be provided in this section. For instance, the applicant may include an explanation of the way the testing methods used are related to the intended use of a medical device in question.
7. Location of complete test report (references to the appropriate test reports).
8. Summary table. The information about the particular non-clinical bench performance tests conducted could also be provided in the form of a summary table.
In summary, the present guidance describes how information about non-clinical bench performance testing should be provided. The document provides additional clarifications on the way such information should be structured and submitted in the context of the various premarket applications. The document addresses the aspects related to both information format and content.
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