The US Food and Drug Administration (FDA) has published a final guidance document titled ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’, copy available from here.
The guidance supersedes the draft issued in May 2018, and includes formatting and content recommendations for test report summaries, test protocols, and complete test reports submitted as part of premarket submissions, such as 510(k)s, PMAs and de novo applications.
The guidance explaians that: “For the purpose of this document, 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, but is not limited to: mechanical and biological engineering performance (such as fatigue, wear, tensile strength, compression, burst pressure); bench tests using ex vivo, in vitro, and in situ animal1 or human tissue; and animal carcass or human cadaveric testing.”
The document continues: “Non-clinical bench performance testing excludes biocompatibility evaluation, reprocessing or sterilization validation, human factors, software verification and validation, and computational modeling because relevant information on these assessments are detailed in associated guidance documents. Test reports for clinical studies, animal studies, and studies evaluating the performance characteristics of in vitro diagnostic devices are also excluded from the scope of this document.”
“To facilitate FDA’s review, we 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 (see Section II.A for more details). 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.”