FDA Asks for Input on Mammogram Quality Data Rules
Published Date: 12/9/2025
Notice
Summary
The FDA wants your thoughts on how it collects info about mammogram quality rules that keep breast screenings safe and reliable. This affects clinics and labs that do mammograms, and the FDA is asking for comments by February 9, 2026. No big money changes, just making sure the paperwork stays clear and helpful!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Large paperwork burden on mammography clinics
If you run a clinic or lab that does mammograms, you must follow Mammography Quality Standards Act paperwork (21 CFR part 900) for reporting and recordkeeping. FDA estimates annual recordkeeping of 244,774 hours and third-party disclosure totaling 4,491,526 hours, notes there are 8,931 certified facilities as of October 1, 2024, and reports an overall decrease of 4,225,729 hours and 321,202 responses in its latest estimate.
Patient-facing lay summaries and records access
If you get a mammogram, facilities must provide a lay summary of your exam and report breast density. FDA estimates 45,414,135 lay summary disclosures annually (about 5 minutes each, totaling about 3,769,373 hours) and 4,644,120 transfers of mammograms/records on patient request (about 371,530 hours).
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Key Dates
Department and Agencies
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