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# Manufacturer Economic Info Communications Q&A Guidance
- URL: https://www.fdaweb.com/manufacturer-economic-info-communications-q-a-guidance/
- Published: 2026-06-02T12:00:00.000Z
- Updated: 2026-09-14T13:40:22.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5161239

FDA has published a draft guidance, *Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities: Questions and Answers*, with answers to common questions about firms’ communication of health care economic information (HCEI) about their prescription drugs and medical devices to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis. The [document](https://www.fda.gov/media/133620/download?ref=fdaweb.com) also addresses common questions relating to the dissemination to payors of information about medical products that are not yet approved or cleared for any use, and dissemination to payors of information about unapproved uses of approved/cleared medical products.

When finalized, the draft will replace a 6/2018 final guidance.

The questions and answers are grouped into two categories: **(1)** communication of HCEI to payors regarding approved/cleared medical products, and **(2)** communications to payors about unapproved medical products and about unapproved uses of approved/cleared medical products.