On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate digital health tools which are regulated as medical devices.  The guidance describes when a Type V drug master file (DMF) can be used to provide information to the Center for Drug Evaluation and Research (CDER) about a device constituent part with electronics and/or software that is planned for use as a platform across multiple CDER-led combination products.

The types of functions these device constituent parts could perform include: