Guide on the Use of Type V Drug Master Files for Combination Products

In October 2019, the FDA issued a draft guideline regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.

DMFs can be helpful marketing authorisation documents containing confidential information on the medicinal product or manufacturer on a voluntary basis. There are 5 types of DMF, whereby meanwhile Type I regarding the Plant Master File has been dropped. DMF V contains information that does not fit into category II - IV.  They refer to electronic or software components that

  • are related to the release of medicinal products
  • provide information for decision making regarding treatment or therapy
  • interface with other medical devices or systems for patient support or health organisations
  • control the properties of user interfaces 

Medical devices in combination with sealing systems (DMF III) are explicitly excluded.

The DMF V can also be used as an update for changes to the combination product.  The DMF V can almost universally be used for other submissions.   

Comments to the Guidance Document Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry can be submitted until 30 December 2019.

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