USA – FDA Drafts Guidance on Type V DMFs for Combination Products

The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about Center for Drug Evaluation and Research (CDER)-led combination products that include a device constituent that may be used in multiple combination products.

DMFs are a voluntary submission to FDA of confidential information about certain aspects related to a drug or manufacturer. There are five types of DMFs, Type II-V (Type I DMFs were discontinued in 2000), with Type V DMFs covering FDA accepted reference information that would not fit in the other DMF types.

Specifically, FDA says the draft guidance applies to CDER-led combination products that incorporate a device constituent with electronic or software components that perform functions such as drug delivery; providing information used to make a decision about a treatment or drug delivery; interface with other devices or systems to transmit information; or control the product’s user interface.

FDA notes that the guidance does not cover combination products where the device constituent is a container closure system, as those may be submitted as a Type III DMF…