US: FDA Proposes DBT Reclassification From PMA to 510(k)

On August 10, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register (91 FR 51406) to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, from class III (premarket approval) into class II (special controls), subject to 510(k) premarket notification. The Agency also proposes a new classification regulation, Digital Breast Tomosynthesis System, to be codified at 21 CFR 892.1717, with special controls that manufacturers must meet for clearance.

Comments on Docket No. FDA-2026-N-7630 are due by October 9, 2026. If finalized as proposed, any final order would take effect 30 days after its Federal Register publication date. For DBT manufacturers selling into the United States, the pathway change is the material event: new and modified systems would shift from PMA to 510(k) once the order is final and effective.

What exactly would change for DBT systems?

DBT systems are postamendments class III devices under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). They have required PMA approval under section 515 since the first system was approved on February 11, 2011. FDA has since approved 3 additional original PMAs and 26 PMA supplements under product code OTE, including 1 panel-track supplement.

Under the official proposed order (PDF), FDA would reclassify those systems into class II pursuant to section 513(f)(3) of the FD&C Act and 21 CFR part 860, subpart C. Premarket notification under section 510(k) would replace PMA for devices within the new identification. The devices remain prescription-use only and stay within the Mammography Quality Standards Act (MQSA) mammographic-modality framework for facilities that perform DBT exams.

Who has to act, and what must manufacturers prepare?

Regulatory affairs and quality teams at DBT system manufacturers with U.S. market plans (including Hologic, GE HealthCare, Siemens Healthineers, Fujifilm, and Planmed among others already active under OTE) must map their next submissions to the proposed special controls and 510(k) evidence plan now, while the docket is open.

FDA's proposed special controls focus on mitigating risks such as corrupted or non-diagnostic images through: (1) bench testing of imaging characteristics (spatial resolution, noise, DQE, detector lag, AEC performance, geometric distortion, missed tissue, alignment/collimation, and radiation dosimetry); (2) objective task-based assessment of diagnostic accuracy (reader studies with human subjects, structured phantoms, in silico methods, or combinations); (3) software verification, validation, and hazard analysis; (4) clinical image evaluation; and (5) labeling that summarizes performance and clinical image evaluation results. FDA expressly recommends a Q-Submission Pre-Submission to align test plans before filing.

Existing PMA holders should inventory pending PMA supplements and pipeline design changes that would, after the effective date, be candidates for 510(k) instead. New entrants should stop planning greenfield PMAs for DBT systems within the proposed identification and build a substantial-equivalence and special-controls package instead.

What should compliance teams do before October 9, 2026?

Submit substantive comments to Docket FDA-2026-N-7630 by 11:59 p.m. Eastern Time on October 9, 2026, if any proposed special control, identification language, or transition expectation would create an unworkable gap for your platform. Flag bench-test methods, in silico acceptance, clinical image evaluation qualifications, and labeling content that need clarification.

In parallel, draft an internal gap analysis against Table 1 of the proposed order (risks to health versus special-control mitigations), assign owners for each control family, and decide whether a Pre-Submission is warranted before the first post-reclassification 510(k). Facilities and service organizations should track MQSA implications separately: physician qualification and facility certification rules under 21 CFR part 900 continue; this order changes the manufacturer's premarket path, not the MQSA facility regime.

Continuous, per-jurisdiction real-time monitoring surfaces Federal Register device reclassifications of this kind the moment they publish, so pipeline plans stay aligned with CDRH's live docket rather than lagged trade summaries.

Take advantage of this real-time watch

Next steps for manufacturers: confirm whether your DBT configuration falls under product code OTE and the proposed 21 CFR 892.1717 identification; freeze a comment strategy before October 9, 2026; open or update a Pre-Submission on special-control test plans; and brief regulatory, clinical, and quality leadership on the PMA-to-510(k) switch that would apply 30 days after any final order. Obsidian keeps this U.S. radiology-device pathway change visible as comments close and a final order approaches.