FDA Tunes Up Mammogram Rules: Keep Scans Sharp and Safe
Published Date: 3/13/2026
Notice
Summary
The FDA is asking for public feedback on renewing rules that keep mammogram centers safe and reliable. These rules affect mammography facilities, making sure their equipment, staff, and practices meet high standards. Comments are due by April 13, 2026, and this process helps protect patients without adding extra costs.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Continued Mammography Certification Rules
The rule keeps in place Federal requirements under 21 CFR part 900 that mammography facilities must be accredited by an FDA-approved accreditation body and then certified by FDA or an FDA-approved State certification agency. Facilities must meet equipment, personnel, quality assurance, and quality control standards and must prominently display their certificate to assure safe, reliable mammography nationwide.
Large Compliance Burden on Facilities
The information-collection renewal documents the compliance burden on mammography facilities, accreditation bodies, and State certifiers with specific estimated hours: annual reporting burden is 12,038 hours (Table 1), recordkeeping burden is 244,774 hours (Table 2), and third-party disclosure burden is 4,491,526 hours (Table 3). The submission notes an overall decrease of 4,225,729 hours and a decrease of 321,202 responses and states there were 8,931 certified mammography facilities as of October 1, 2024.
Patient-Facing Reporting Requirements
The rule requires patient-facing reporting such as a lay summary of the examination and breast density reporting in mammography reports. The document quantifies these burdens: the lay summary activity is estimated at 3,769,373 total annual hours and breast density reporting (one-time burden) is estimated at 205,413 hours.
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Key Dates
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