Guidelines & Regulations News Regulations Technology & Innovation | August 10, 2026

FDA Proposes a New Regulatory Path for Digital Breast Tomosynthesis

The proposed shift from Class III to Class II would change how new DBT systems reach the U.S. market, but it would not reduce MQSA requirements for mammography facilities.

FDA DBT reclassification moved to the center of the breast-imaging regulatory conversation this month after the agency proposed moving digital breast tomosynthesis systems from Class III to Class II. If finalized, the change would replace the premarket approval pathway for new DBT systems with the less burdensome 510(k) pathway, supported by a defined set of special controls.

The FDA DBT reclassification proposal is consequential, but it is also easy to overstate. FDA has not finalized the change, and the current requirements remain in place. Just as importantly, reclassification would not relax the Mammography Quality Standards Act obligations that govern facilities, personnel, accreditation, inspections and quality control.

Why FDA DBT reclassification is being proposed

DBT entered the U.S. market through Class III premarket approval, beginning with the first system approval in 2011. FDA now argues that more than a decade of clinical use, postmarket information and technical development has produced enough evidence to regulate the technology through Class II special controls.

The agency cites four original premarket approvals, numerous supplements, a large body of published evidence and broad adoption. In its proposal, FDA reported that 94% of MQSA-certified facilities had DBT units as of July 21, 2026. The agency also reviewed medical device reports and recall history and said it did not identify safety signals that would require continued Class III regulation.

Five changes breast-imaging leaders should understand

1. New systems could use the 510(k) pathway

A finalized rule would allow manufacturers to demonstrate substantial equivalence through a 510(k) submission rather than complete a full premarket approval application. That could reduce development time and regulatory cost, potentially opening the market to more products and faster iteration. It would not mean that new systems could enter the market without FDA review.

2. Special controls would become the regulatory backbone

FDA proposes detailed requirements for image-quality and performance testing, clinical image evaluation, software verification and validation, electrical and mechanical safety, biocompatibility and labeling. The proposed controls also address dose, breast coverage, compression, reconstruction performance, cleaning and disinfection, and quality-control procedures.

3. Objective task-based assessment would remain central

The proposal calls for evidence that a system performs the diagnostic tasks for which it is intended. Depending on the device, that evidence could come from human reader studies, structured phantom observer studies or in silico testing. Reclassification therefore changes the pathway, not the expectation that a manufacturer must establish clinically meaningful performance.

4. MQSA responsibilities would not change

DBT remains a mammographic modality under MQSA. Facilities would still need appropriate certification and accreditation, qualified personnel, equipment quality-control programs and compliance with inspection standards. A Class II label on a future system would not alter the daily responsibilities of a mammography program.

5. The rule could influence purchasing and lifecycle planning

A broader 510(k) market could eventually affect product choice, software updates, competition and service planning. For now, administrators should avoid making purchasing assumptions before a final order is published. The more immediate task is to understand the proposed controls and determine whether the organization has comments supported by operational or clinical experience.

What happens next

FDA is accepting comments through October 9, 2026, under docket FDA-2026-N-7630. The agency may modify the proposal after reviewing public input. If it issues a final order, the proposed effective date would be 30 days after publication.

For breast-imaging practices, the right posture is attention rather than alarm. The proposal recognizes that DBT has become a mature, widely used modality. It also preserves the core idea that mammography equipment must be evaluated against rigorous, transparent controls before it is used in patient care.

Read the FDA proposal in the Federal Register.

This article is for educational and informational purposes and is not legal, regulatory or clinical advice.