FDA Announces Availability of Draft Guidance – Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software

FDA Announces Availability of Draft Guidance – Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software

FDA Announces Availability of Draft Guidance – Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software

Today FDA announced the availability of a draft guidance for industry entitled "Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software."  A drug master file (DMF) is a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.  This draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., a CDER-led combination product) and which features a device constituent part with electronics and/or software that is planned to be used as a platform, that is, may be used in multiple CDER-led combination products.  The guidance also describes the administrative process and outlines the recommended content for these Type V DMF submissions and amendments. 

Multiple centers, offices, and divisions within FDA may review an application for a CDER-led combination product that features a device constituent part with electronics and/or software used as a platform across multiple products.  For such combination products, a Type V DMF can be an efficient mechanism to provide information regarding the device constituent part when the same information is applicable to several CDER applications.  Once FDA reviews the Type V DMF device information for one CDER application, its review may be applicable to other CDER applications if the device information remains unchanged and is pertinent to products in other CDER applications that also incorporate the DMF by reference. FDA’s ability to use previously completed scientific reviews for a DMF can contribute to an efficient FDA review process and help ensure consistency across CDER applications referencing the same information.

A Type V DMF is intended for the submission of FDA-accepted reference information and supporting data that are not covered by DMF Types II–IV. For additional information on identifying the types of DMFs that may be submitted, see the draft guidance for industry Drug Master Files (October 2019) and FDA’s DMF web page for drugs