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).
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in