USFDA Med Dev Guidances: Intent to Exempt Certain Unclassified Medical Devices & Drug and Device Manufacturer Communications– Questions and Answers

Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers.

The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements, reflects FDA's ongoing commitment to risk-based regulation by proposing exemptions for selected low-risk medical devices.

Although these guidances address different stakeholder groups, both demonstrate FDA's broader strategy of promoting informed decision-making while reducing unnecessary regulatory burden.

Part 1: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities

Healthcare payors and formulary decision-makers play an increasingly influential role in determining patient access to medical products. Decisions regarding reimbursement, formulary placement, coverage restrictions, and healthcare resource allocation are often made long before a product reaches widespread clinical use.

Recognizing the importance of these decisions, FDA has updated its guidance on communications between manufacturers and payors. The revised guidance expands upon previous recommendations and incorporates legislative updates that extend certain provisions to medical devices in addition to drugs and biologics.

The guidance seeks to ensure that healthcare decision-makers receive meaningful, scientifically supported information while maintaining safeguards against misleading or incomplete communications.

The updated guidance reflects:

• Changes introduced through the Consolidated Appropriations Act

• Expansion of healthcare economic information provisions to medical devices

• Growing reliance on value-based healthcare models

• Increased demand for early product information by payors

• Advances in health economics and outcomes research methodologies

These developments created a need for updated regulatory recommendations that better align with modern healthcare decision-making practices.

Understanding Healthcare Economic Information (HCEI)

Healthcare Economic Information (HCEI) refers to analyses that evaluate the economic consequences associated with the use of a medical product. These analyses may incorporate clinical outcomes, resource utilization, healthcare costs, quality-of-life measures, and comparative effectiveness data.

Unlike traditional promotional claims focused primarily on safety and efficacy, HCEI allows payors to evaluate the broader economic impact of adopting a therapy within a healthcare system.

Competent and Reliable Scientific Evidence (CARSE)

A central concept within the guidance is the requirement that HCEI be based on Competent and Reliable Scientific Evidence (CARSE). FDA expects economic analyses to be developed using accepted scientific principles and recognized methodologies. The quality of evidence should be appropriate for the claims being communicated.

FDA Expectations for Transparent Communication

To support informed decision-making, manufacturers should provide sufficient context regarding the analyses presented.

Communications Regarding Investigational Products

Payors often require information about products that are still under development to support future coverage and budgeting decisions. The guidance outlines circumstances under which manufacturers may communicate information regarding:

• Investigational products

• Products under FDA review

• New indications under development

• Unapproved uses of approved products

Permitted information may include:

• Product descriptions

• Clinical trial status

• Development timelines

• Epidemiological projections

• Pricing considerations

• Patient utilization estimates

However, manufacturers must avoid presenting investigational products as approved, safe, or effective prior to FDA authorization.

Part 2: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements

FDA's second guidance focuses on reducing regulatory burden for selected low-risk medical devices. Through this initiative, FDA intends to exempt certain unclassified devices from Premarket Notification (510(k)) requirements. The proposal reflects FDA's risk-based regulatory philosophy, which seeks to tailor regulatory requirements according to the level of risk presented by a device.

Understanding Premarket Notification (510(k))

The 510(k) process requires manufacturers to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device before commercialization.

The process typically involves:

• Device descriptions

• Intended use information

• Performance testing

• Labeling review

• Comparative assessments

While essential for many products, FDA recognizes that certain low-risk devices may not require this level of regulatory review.

Why FDA Is Considering Exemptions

Over time, FDA has gained significant experience with many low-risk device categories. For certain products, extensive post-market experience and established safety profiles indicate that premarket notification may provide limited additional public health benefit.

FDA's exemption initiative seeks to:

• Reduce unnecessary regulatory burden

• Improve regulatory efficiency

• Accelerate patient access

• Support innovation

• Focus FDA resources on higher-risk technologies

Device Categories Included in the Proposal

The guidance identifies several categories of unclassified devices eligible for exemption.

Examples of Device Categories

Category	Examples
Ear, Nose and Throat	Hearing protection devices
Gastroenterology and Urology	Low-risk support devices
General and Plastic Surgery	Selected accessories
Obstetrical and Gynecological	Fertility-related products
Physical Medicine	Monitoring devices
Neurological	Low-risk therapeutic devices
Toxicology	Certain testing products
Ophthalmic	Eye-care accessories

FDA determined that these products present sufficiently low risk to support exemption from premarket notification requirements.

Impact on Medical Device Manufacturers

For manufacturers of low-risk devices, exemptions may significantly simplify regulatory pathways and reduce administrative burden.

Potential outcomes include:

• Faster product launches

• Lower compliance costs

• Increased competitiveness

• Improved resource allocation

• Greater innovation opportunities

These changes are particularly beneficial for smaller manufacturers and emerging companies developing low-risk technologies.

Together, these guidances highlight FDA's broader effort to balance innovation, efficiency, and patient protection while supporting the evolving needs of the healthcare ecosystem.

References

1. Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers

2. Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements