CPC Comments on FDA’s “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry”

On December 26, 2019, the CPC provided comments on FDA’s “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry.” The CPC believes regulatory efficiency and consistency can be improved by the approach proposed by the Agency, which can lead to timely access to new combination products for patients.  To ensure utilization of this approach, however, the CPC strongly recommends that the Draft Guidance better clarify how the rapid, iterative nature of software updates are considered in the process, submissions and amendments for Type V DMFs that contain electronics or software.  In addition, the CPC believes that the Draft Guidance should clarify that the proposed Type V DMF submission approach should be available to all types of platform device constituent parts, not just those containing electronics or software.