FDA has proposed reclassifying digital breast tomosynthesis (DBT) systems from Class III to Class II.
If finalized, the change would replace the current PMA framework for these systems with Class II special controls plus 510(k) premarket notification requirements.
For manufacturers, this could materially change both new-product submissions and lifecycle-management strategy.
What Happened?
FDA published the proposed reclassification on August 10, 2026. The agency says accumulated experience with DBT systems supports moving them from Class III to Class II provided appropriate special controls apply.
This is still a proposal.
Existing manufacturers should not immediately redesign their submission procedures around a final Class II framework that does not yet exist.
Why It Matters
Class III PMA and Class II 510(k) are very different regulatory pathways.
If FDA completes the reclassification, DBT manufacturers could see a different evidentiary and submission model for future systems and modifications.
FDA nevertheless makes clear that Class II would not mean “low regulatory scrutiny.”
The proposed special controls address risks including corrupted or non-diagnostic images, diagnostic performance and radiation-related concerns.
What Would the Special Controls Cover?
FDA proposes controls that include performance testing and objective task-based assessment of diagnostic accuracy, using approaches such as human subjects, structured physical phantoms, in-silico methods or combinations depending on the technology. Appropriate software verification, validation and hazard analysis are also contemplated.
This makes the practical message quite clear:
The pathway may become less burdensome, but the technical file does not become simple.
What Changes in Practice?
Manufacturers should evaluate how the proposal could affect:
- regulatory strategy;
- predicate strategy;
- bench-testing plans;
- image-quality testing;
- clinical/performance evidence;
- software verification and validation;
- risk management;
- cybersecurity where applicable;
- labeling;
- device modifications.
FDA also notes the potential use of Predetermined Change Control Plans (PCCPs) for appropriate future modifications, which can allow changes covered by an authorized plan without a new 510(k) for each modification.
For software-intensive imaging systems, that could become strategically important.
What Should Manufacturers Do Now?
A practical response would be to conduct a regulatory impact assessment rather than changing procedures immediately.
Review:
- Products currently under PMA or supplement planning.
- Pipeline DBT systems.
- Planned software and algorithm changes.
- Existing performance-test methods.
- Risk controls against FDA’s proposed special controls.
- Whether a PCCP strategy could become relevant.
- Submission SOPs that distinguish PMA, supplement and 510(k) pathways.
Common Risk
The biggest mistake would be interpreting “Class II” as “minimal evidence.”
FDA’s proposal is explicitly based on pairing general controls with detailed special controls.
Teams should therefore focus less on the class number and more on what evidence those special controls will actually require.
Practical Example
Imagine a manufacturer developing a next-generation DBT platform with substantial software improvements.
Under the current Class III environment, the company might structure its regulatory plan around PMA requirements and supplements.
If reclassification is finalized, the same company may instead need to build a 510(k) strategy demonstrating substantial equivalence while satisfying DBT-specific special controls and perhaps consider a PCCP for defined future software modifications.
That could change product-roadmap decisions before a submission is ever assembled.
Has FDA already reclassified DBT systems?
No. FDA has proposed the reclassification.
Would DBT systems become 510(k) devices?
That is FDA’s proposed approach: Class II with special controls and 510(k) requirements.
Does Class II eliminate performance testing?
No. FDA proposes specific performance and diagnostic-accuracy controls.
Could software changes use a PCCP?
FDA specifically discusses PCCPs as a possible approach for qualifying future modifications.
What should manufacturers do now?
Assess pipeline products and evidence plans against the proposed controls while waiting for the final regulatory decision.