FDA drafts guidance on Type V DMFs for combination products
The FDA on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about CDER-led combination products that include a device constituent that may be used in multiple combination products.
DMFs are a voluntary submission to the 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Specifically, the FDA says the draft guidance applies to CDER-led combination products that incorporate a device constituent with electronic or software components that perform functions such as drug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.
The 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.
“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, and additional measures to ensure consistency are needed,” the FDA writes.
The FDA also notes that because device technology changes rapidly, making amendments to a Type V DMF is an appropriate pathway for reporting changes to the FDA for combination products.
The FDA explains that once it reviews a Type V DMF for a device, “its review may be applicable to other CDER applications if the device information remains unchanged and is pertinent to other CDER applications that also incorporate the DMF by reference,” which the agency says would facilitate more efficient and consistent reviews.
However, the FDA notes that the guidance “does not address FDA premarket review standards or expectations” for device constituents and that sponsors should not submit a Type V DMF to CDER if the same information is contained in a device master file held by another center at the agency.
The guidance also describes the administrative procedure for submitting and reviewing DMFs and makes recommendations on the content that should be included in Type V DMF submissions, amendments and annual reports.
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