The FDA's New MQSA Facility Portal: What Every Certified Mammography Facility Must Do Before October 22, 2026
A MammoComply Regulatory Advisory for Client Facilities
Richard D. Lippert Jr.
President & Founder, Mammologix · Breast Imaging Operations since 1995
Starting October 22, 2026, the FDA will stop mailing MQSA certificates and move delivery to its new Facility Portal. Here is what is changing, who is exempt, and the concrete steps to take before the September 14 transition window opens.
In this article
What's Changing
Effective October 22, 2026, the FDA will stop mailing MQSA certificates and certification-related letters, moving delivery instead to a new online system: the MQSA Facility Portal. From September 14 through October 22, 2026, facilities may receive dual delivery: a mailed copy and a portal notification email for the same document. After October 22, expect portal-only delivery, with no mail backup.
What Doesn't Change
The legal duty to prominently display a printed MQSA certificate on-site is unchanged. Portal access alone does not satisfy that duty: on any portal notice involving a certificate update, the facility is still responsible for downloading, printing, and posting the certificate.
Who Is Exempt
Facilities certified through a State Certifying Agency (SAC) in Illinois, Iowa, South Carolina, or Texas are not affected by this change; those states continue issuing certificates through their existing process. One nuance worth knowing: a federal facility physically located in one of those four states is still FDA-certified, not SAC-certified, since FDA has not delegated certification authority to any state for federal facilities.
Who Receives the Notifications
Portal emails go to three contacts collected during your annual inspection: the Accreditation Contact, the Most Responsible Individual, and the Inspection Contact. If any of those three point to a shared inbox, a former employee's address, or an unmonitored account, a notice can be delivered successfully and still go unseen.
What To Do Before September 14, 2026
- Confirm whether each of your locations is FDA-certified or SAC-certified.
- Verify the three FDA inspection contacts are current, working, and monitored.
- Add the FDA's certification email address to your approved senders list.
- Assign clear ownership of portal login and one-time-passcode handling.
- Refresh your download, print, and display procedure so a portal notice converts smoothly into a posted certificate.
Why It Matters
Nothing about your underlying accreditation, quality-standard, or inspection obligations is changing, only how the paperwork arrives. But a pending-expiration letter is issued only 10 calendar days before expiration, and CMS treats a current, displayed MQSA certificate as a condition of Medicare and Medicaid payment eligibility. A delayed portal retrieval can compress an already tight timeline.
The full advisory below includes the complete FDA-listed certificate and letter types, the full facility checklist, the SAC-state carve-outs, and the complete reference list.
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The FDA's New MQSA Facility Portal: Full Regulatory Advisory
The complete advisory: every FDA-listed certificate and letter type that triggers a portal notice, the full facility checklist, the SAC-state carve-outs, and the full AMA-style reference list.
About the Author
Richard D. Lippert Jr.
President & Founder, Mammologix · Breast Imaging Operations since 1995
Founder of Mammologix, Richard D. Lippert Jr. has spent more than 30 years in breast imaging operations, from clinical practice and hospital radiology administration to building specialized service platforms for imaging centers nationwide. His work spans mammography tracking, lay communication, FDA/MQSA-related support, medical outcome audit, and the operational systems that help facilities stay compliant and keep patients from falling through the cracks.
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