FDA Downgrades Fancy Mammogram Machines to Less Scary Category
Published Date: 8/10/2026
Proposed Rule
Summary
The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Digital Breast Tomosynthesis System," to identify these devices along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
Analyzed Economic Effects
6 provisions identified: 4 benefits, 2 costs, 0 mixed.
FDA Identifies Ten Health Risks From DBT
FDA lists probable health risks tied to DBT systems, including corrupted or non-diagnostic images; incorrect image interpretation; inadequate breast coverage; inappropriate compression; device failure or malfunction; user error; excessive x-ray exposure; interference with other devices; adverse tissue reaction; and infection. These risks could lead to delayed or incorrect diagnosis, extra radiation exposure, unnecessary procedures, or patient injury.
DBT Devices Shift From PMA to 510(k)
FDA proposes to reclassify digital breast tomosynthesis (DBT) systems from class III (which require a Premarket Approval or PMA) to class II, meaning manufacturers would submit a premarket notification (a 510(k)) instead of a PMA before marketing. FDA says a 510(k) is generally less burdensome and may shorten review timelines, which could lower the regulatory cost and speed market entry for device makers.
You May See More DBT Availability
FDA says reclassifying DBT systems to class II could enable more manufacturers to develop these devices and provide more timely patient access to DBT for breast cancer screening and diagnosis. If finalized, FDA expects increased device availability and patient access as a result of the less burdensome 510(k) pathway.
DBT Facilities Must Follow MQSA Rules
FDA states that DBT is a mammographic modality under the Mammography Quality Standards Act (MQSA), so facilities that perform mammography using DBT systems are subject to MQSA requirements. That means facilities using DBT must meet MQSA standards and QC requirements when they offer these exams.
Postmarket Data Shows Limited Serious Safety Signals
As of July 21, 2026, FDA report searches found 968 Medical Device Reports for DBT systems, about 1 percent reported serious injury (not necessarily device-caused), five Class II recalls, and no Class I or Class III recalls. FDA says most MDRs indicated no patient impact and that the postmarket data support special controls rather than PMA-level oversight.
Manufacturers May Use Predetermined Change Plans
FDA notes that manufacturers may use Predetermined Change Control Plans (PCCPs) approved or cleared by FDA to implement future device modifications without submitting a new 510(k) or PMA supplement for each change, under section 515C of the FD&C Act. Using PCCPs can reduce the need for separate submissions when changes fall within the approved plan.
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