FDA Revises Payor Communications Draft Guidance to Cover Medical Devices

The US Food and Drug Administration has issued a revised draft guidance on how drug and medical device makers may communicate with health insurers, formulary committees and similar bodies, bringing devices formally into a framework that until now was written around a 2018 final guidance. The agency announced the document in a Federal Register notice published on June 3.

The guidance, titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers," covers health care economic information (HCEI) about approved prescription drugs and approved or cleared devices. It also addresses what firms may tell payors about products that are not yet approved or cleared, and about unapproved uses of products already on the market. According to the notice, the revised draft, when final, "will replace the final guidance of the same title issued in June 2018."

What changed in the law

The revision follows section 3630 of the Consolidated Appropriations Act, 2023, which the notice says amended section 502(a) of the Federal Food, Drug, and Cosmetic Act "to make the provisions regarding communication of HCEI to payors under section 502(a) applicable to devices." The same law added a new section 502(gg), which provides that a drug or device will not be deemed misbranded under section 502(f)(1) because of certain truthful and not misleading information given to payors about investigational products or investigational uses.

The notice states that FDA does not intend to object under section 502(f)(1) to a firm's communication with payors about unapproved products or unapproved uses, even where they may not be considered investigational, if the communication is consistent with section 502(gg). The agency defines payors as entities that make coverage, reimbursement, formulary or product-selection decisions on a population basis, which may include integrated delivery networks, hospitals and hospital systems.

FDA said it had already included device recommendations in the 2018 guidance, so the revision adds no new paperwork burden beyond what was estimated then. Using 2023 submission data, the agency estimated that about 260 manufacturers will disseminate 2,600 distinct HCEI materials for approved or cleared devices each year, alongside about 600 manufacturers and 7,800 materials for prescription drugs.

Balancing payor needs and premarket review

As reported by Regulatory Focus, the news service of the Regulatory Affairs Professionals Society, FDA issued the revised draft on June 2 and framed it as an attempt to balance payors' planning needs against its public health responsibilities. The agency wrote that "Some firms’ communications regarding unapproved medical products or unapproved uses of approved/cleared medical products may undermine substantial government interests related to health and safety."

FDA also acknowledged that payors often must plan coverage and reimbursement decisions well before a product reaches the market. "FDA recognizes the value of payors receiving truthful and not misleading information about unapproved medical products and unapproved uses of approved/cleared medical products, as described in section 502(gg) of the FD&C Act, in order to inform their decision-making," the agency said, according to Regulatory Focus.

The draft is not for implementation. FDA is taking comments through August 3, 2026, under docket number FDA-2016-D-1307, before it begins work on a final version.