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# Guide on How to Prepare Combination Product Designation Request
- URL: https://www.fdaweb.com/guide-on-how-to-prepare-combination-product-designation-request/
- Published: 2018-02-16T12:00:00.000Z
- Updated: 2026-09-14T23:23:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140779

*Federal Register* notice: FDA has made available a guidance entitled “How to Prepare a Pre-Request for Designation (Pre-RFD)” that explains the Office of Combination Product’s Pre-RFD process the type of information needed to obtain a preliminary assessment from the agency. The Pre-RFD process is available to provide informal, non- binding feedback about the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, it provides information about a non-combination or combination product’s assignment to the appropriate agency Center. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-16/pdf/2018-03230.pdf?ref=fdaweb.com).