As we have seen in the last few weeks the Food and Drug Administration (FDA) is making a big push to end 2019 on a “high-note” and provide as much clarity on submission expectations for future applications. As we discussed in the last blog, the FDA finalized their expectations regarding e-Copy and electronic submissions, and this week FDA finalized a guidance document: “to describe 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.”
FDA’s aligned approach to medical device premarket evaluation requests submitters to consider a “least burdensome approach,” utilizing a minimum amount of information to adequately support an application or device requirement. The guidance,"Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff", endorses a least burdensome approach by recommending a high-level summary of the non-clinical test studies that are performed for pre-market applications such as Q-submissions (Q-subs) or Investigational Device Exemptions (IDEs).
Another important application opportunity is that submitters have the choice of including the recognized consensus standards, which will identify and provide instructions for testing, test methodology, number of samples and performance limits to explain their conformance strategy. The key to the study table is the acceptance criteria. The acceptance criteria provide the specification range that is prospectively identified, including acceptance and rejection criteria, with a scientific and technical rationale for these criteria when applicable. The acceptance criteria should be supported by the specific performance needs of the device (based on design goals), the intended use and indication for use of the device.
This is included in the CDRH Premarket Review Submission Cover Sheet (Form FDA 3514). “If a manufacturer elects to conform to one or more FDA-recognized consensus standards to satisfy part of a premarket review requirement, the manufacturer must submit a "Declaration of Conformity" to the standard(s) (221 U.S.C. 360d(c)(1)(B)).”
If any conducted testing is not final, FDA recommends that the status and proposed date of completion be identified in the testing summary table, along with scientific rationale for why this strategic method is appropriate.
This final guidance document provides a recommendation to industry that has a broad-based approach to streamlining the application process for the industry, which can be used across other platforms; but prefers to provide these helpful hints to a more “traditional” document preparation audience.
Boudicca Dx., LLC has the expertise to support the planning, designing and review of non-clinical studies provided in FDA submissions allowing clients to streamline their product development processes towards Health Authority recommendations of a “least burdensome“ approach. Reach out to email@example.com for further details about Boudicca Dx LLC’s, medical device submission study design capabilities.
Guidance for Industry and Food and Drug Administration Staff: Recommended Content and Format of
Non-Clinical Bench Performance Testing Information in Premarket Submissions. Document issued on December 20, 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-non-clinical-bench-performance-testing-information-premarket?utm_campaign=2019-12-23%20CDRH%20New&utm_medium=email&utm_source=Eloqua
FDA Guidance “eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff,” available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/ecopy-program-medical-device-submissions.