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# Type 5 DMFs for Drug-led Combo Product Guide
- URL: https://www.fdaweb.com/type-5-dmfs-for-drug-led-combo-product-guide/
- Published: 2019-10-28T12:00:00.000Z
- Updated: 2026-09-15T01:59:14.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5145352

FDA has released a [draft guidance](https://u7061146.ct.sendgrid.net/wf/click?upn=G62jSYfZdO-2F12d8lSllQB3j5Gq3KbunC3oB8Bum3HlfQ7K9VB0YJ23rIAbgjXkd2SUys-2FPhV3UJT9xl9D2wn9-2BbRuo6jGS3qo1vBJIticBCmNCUIWz-2BU65kEbBqrtQRLsemW4MUKckeCN94wcJwBatKYoevHs3YtJYOkLnbx6Yv9v9j49hxd-2FzvT-2BhlU29Px7oJIOg&ref=fdaweb.com) on “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software.” A drug master file (DMF) is a voluntary submission that provides confidential detailed information about facilities, processes, or articles used in the manufacturing one or more human drugs. The document explains when a Type V DMF may be used to submit information regarding a combination product for which CDER has primary jurisdiction. It also describes the administrative process and outlines the recommended content for such submissions and amendments.

“Once FDA reviews the Type V DMF device information for one CDER application, its review may be applicable to other CDER applications if the device information remains unchanged and is pertinent to products in other CDER applications that also incorporate the DMF by reference,” the guidance says. “FDA’s ability to use previously completed scientific reviews for a DMF can contribute to an efficient FDA review process and help ensure consistency across CDER applications referencing the same information.”