Submit Comments by 08/03/2026
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s docket number: FDA-2016-D-1307
Docket Number: FDA-2016-D-1307 Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
OMB Control Number: 0910-0686
Expiration Date: 11/30/2026
This guidance provides answers to common questions concerning firms’ communication of health care economic information (HCEI) regarding 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 (collectively referred to as payors). This guidance also addresses common questions relating to dissemination to payors of information about medical products that are not yet approved or cleared for any use (collectively referred to as unapproved medical products) and dissemination to payors of information about unapproved uses of approved/cleared medical products.
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Content current as of:
06/02/2026
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Regulated Product(s)
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