Guidelines & Regulations News Screening | August 1, 2026

FDA's August MQSA Scorecard Shows DBT at Nearly 95% of Certified Facilities

The latest federal snapshot also shows more than 44.8 million annual mammography procedures and no cited noncompliance at 83.5% of inspected facilities.

The FDA MQSA scorecard 2026 update offers a useful snapshot of the scale and condition of U.S. mammography services. As of August 1, FDA reported 9,118 certified facilities, 27,692 accredited mammography units and 44,864,442 annual procedures.

The numbers do not describe every local access problem or quality challenge. They do, however, show a system in which digital breast tomosynthesis has become nearly universal at the facility level and most inspected sites had no cited noncompliance.

Five numbers from the FDA MQSA scorecard 2026

1. There are 9,118 certified mammography facilities

The August count represents a modest increase from 9,107 in July and 9,099 in June. Facility counts alone cannot show whether capacity is evenly distributed, but stability matters at a time when many communities face staffing shortages, rural access barriers and rising demand.

2. DBT is present at 8,638 facilities

That means approximately 94.7% of certified facilities had at least one accredited DBT unit. The scorecard lists 13,515 accredited DBT units, compared with 14,177 accredited 2D digital units. Because a facility may have both types of accreditation, these figures should not be added together to estimate unique machines.

3. Annual procedure volume exceeds 44.8 million

FDA reported 44,864,442 annual mammography procedures as of August 1. This is a national activity measure reported through the MQSA program, not a count of unique women screened. It includes the broader mammography workload and underscores the operational consequences of small improvements in scheduling, interpretation, follow-up and equipment uptime.

4. More than 7,100 facilities had been inspected

During fiscal year 2026, 7,184 facilities and 21,493 units had been inspected by August 1. MQSA inspection data provide one view of compliance, but they should not be interpreted as a complete measure of clinical quality, patient experience or diagnostic performance.

5. Most inspections showed no noncompliance

FDA reported no cited noncompliance at 83.5% of inspections. The highest finding was Level 1 noncompliance at 1% of inspections and Level 2 at 15.6%. Those percentages reflect the highest level identified at an inspection, not the number of individual findings.

What the scorecard can and cannot tell us

The FDA MQSA scorecard 2026 is encouraging in several respects. DBT access has expanded rapidly, the national facility count is stable and most inspected programs meet the reviewed requirements without a citation. These are meaningful system-level signals.

But a national count can conceal geographic and socioeconomic gaps. A DBT unit located hours away does not represent practical access for a woman without transportation, paid time off or childcare. Likewise, equipment availability does not guarantee an appointment if a program lacks technologists, interpreting physicians or timely diagnostic follow-up.

The data also should not be used to rank individual facilities. MQSA certification establishes a critical quality floor, while strong breast-imaging programs build beyond that floor through outcome auditing, communication, workforce development, patient navigation and reliable escalation of abnormal findings.

Why these numbers matter now

FDA is separately considering whether DBT systems should move from Class III to Class II regulation. The widespread adoption documented in the scorecard is part of the context for that proposal. The technology is no longer emerging; it is embedded in routine U.S. mammography.

For facility leaders, the FDA MQSA scorecard 2026 is best used as a benchmark and a prompt. National compliance is strong, but every program still needs to examine its own access, quality and follow-up measures. The work of breast imaging is not only acquiring a mammogram. It is ensuring that the right examination is performed well, interpreted accurately and connected to the next step without avoidable delay.

Related: Five important implications of FDA’s proposed DBT reclassification. Explore the FDA’s complete 2026 MQSA scorecard.

Percentages in this article were calculated from FDA’s August 1, 2026 facility counts and rounded to one decimal place.