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# Guide on Type V DMFs for CDER-Led Combo Products
- URL: https://www.fdaweb.com/guide-on-type-v-dmfs-for-cder-led-combo-products/
- Published: 2019-10-29T12:00:00.000Z
- Updated: 2026-09-15T01:59:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145371

*Federal Register* notice: FDA has made available a draft guidance for industry entitled “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software.” 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 such submissions and amendments. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-29/pdf/2019-23585.pdf?ref=fdaweb.com).