FDA’s newest Guidance document: Recommended Content and Format of Test Reports for Complete Non-Clinical Bench Performance Testing in Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff; May 31, 2018, isn’t really “new news” but certainly formalizes the expectations FDA has had for test reports for many years. This expectation is for complete original test reports to be included in submissions that include non-clinical testing. The guidance still recommends including a summary report in the body of submission that summarizes the testing conducted in addition to the reports themselves.
A summary report too? Really? I struggle with this “extra” work since a good test report should have all the information FDA is looking for in a tabulated summary as required by the new guidance. This seems like a copy/paste exercise to me. Does it really add value or save the reviewer time? The reviewer will read (or is expected to read) the complete test reports anyway. Will they take the time to then cross-check the summary table to ensure the content matches each individual report? The amount of time to create such a summary table could be enormous. And if this is expected for software testing reports; not manageable.
Don’t get me wrong, I agree that a table summarizing the non-clinical testing can be valuable but a concise table would be more beneficial with a snapshot of ALL test reports contained in the submission, a brief description of each, and that’s about it. This would provide “testing conducted at a glance” and would not take a large amount of time to create and would benefit both FDA and the manufacturer. The specific and detailed information is then found in the attached reports anyway.
Now on to the test report formats themselves. The real kicker here is under Test Sample Information where the guidance states: “The tested devices should represent the final, finished device that has been subjected to all manufacturing processes (including sterilization), environmental conditioning and simulated transportation.” How many manufacturers conduct full verification testing AFTER ship testing? Not any place I’ve ever worked. This requirement limits the ability of engineering to troubleshoot issues, was it the distribution that caused an issue or just a faulty design or component? The guidance does indicate that if testing is not performed using such samples, then you have to state such and justify why the approach taken is appropriate.
There is a similar quandary with Test Sample Selection where it states that “your test sample selection should consider both inter- and intra-lot variability by examining multiple manufacturing lots, when appropriate”. In most cases project development timelines and cost reasons will dictate ‘when appropriate’ and generally lot variability is addressed in process validations, not design verification.
You too can voice your opinion by submitting electronic comments and suggestions regarding this draft document to FDA by July 30, 2018 to www.regulations.gov.
Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
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Lorry Weaver Huffman