Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated primarily as a drug
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’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