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  1. Mammography Quality Standards Act (MQSA) and MQSA Program

MQSA Certificate Delivery Process

What's Changing

Effective October 22, 2026, the U.S. Food and Drug Administration (FDA) will no longer mail Mammography Quality Standards Act (MQSA) certificates or certification-related letters. Instead, these documents will be provided through a new online system called the MQSA Facility Portal.  It will be the responsibility of the facility to download the FDA-issued MQSA certificates and certification-related letters. There will be a transition period beginning September 14, 2026, until the final implementation date, October 22, 2026.  During this time, it is possible that facilities will receive both an MQSA certificate and/or a letter via the U.S. Postal Service and a notification email with instructions to retrieve the MQSA certificate or certification-related letters from the MQSA Facility Portal.

For facilities certified by an FDA-approved State Certifying Agency (SAC), which currently are the States of Illinois, Iowa, South Carolina, and Texas, the process described in this letter does not apply to them. Issuance of mammography certificates by FDA-approved SACs will not change.  

How it Works

When any of the following actions occur regarding a facility's certification, the facility will receive an email notification from the Division of Mammography Standards (fdsa_mqsa_certs@fda.hhs.gov) (PLEASE DO NOT REPLY TO THIS EMAIL ADDRESS, IT IS A SEND-ONLY ACCOUNT)

  • 3-Year Certificate - Issued when a facility receives full accreditation and certification. If the mammography units are accredited and certified under the same MQSA Facility ID number (or MQSA certificate ID) additional certificates may be printed, if needed, through the MQSA Facility Portal. There will be the option to choose a certificate in Spanish. Certificates in either language will be available through the MQSA Facility Portal.
  • Replacement/Duplicate Certificate - Issued when a facility needs a replacement for a lost/misplaced certificate, or when a facility wants a duplicate certificate to display. Replacement or duplicate certificates will be available from the original electronic file you received through the MQSA Facility Portal for as long as that certificate is active.
  • Provisional Six-Month New Facility Certificate - Issued to new, first time, accredited and certified facilities.
  • Provisional Six-Month Reinstatement Certificate - Issued to facilities, after accreditation body (AB) review and approval, when more time is required to gain full 3-year accreditation.
  • 90-Day Extension - Issued to provisionally accredited and provisionally certified facilities that may need more time to gain 3-year accreditation. Note: The extension is issued one time, and facilities must apply for this through their AB.
  • Interim Notice (45 Days) - Issued to fully accredited and certified (3-year) facilities, that may need more time to gain their next full accreditation and certification.
  • Facility Name Change - Issued to facilities that change their name.  Note: If the facility has a name change, contact the facility’s AB to report the name change and the FDA will then issue an updated certificate once the AB notifies FDA of the name change.
  • AB Switch - Issued when a facility switches its AB.
  • Pending Expiration Letter - Issued to facilities ten (10) calendar days before certification expires.
  • No Longer Certified Letter - Issued when a facility's certification lapses or is revoked or a facility withdraws and/or closes.
  • Denied Accreditation Letter - Issued to a provisionally accredited and certified facility when its unit(s) has not met the quality standards under the MQSA.
  • Denied Reaccreditation Letter - Issued to a certified facility when its unit(s) has not met the quality standards under the MQSA.
  • Three Unsuccessful Attempts at Accreditation Letter - Per 21 CFR 900.4(a)(6)(ii), if a facility fails to become accredited after three consecutive attempts, no FDA-approved AB is permitted to accept a new application from that facility for 1 year from the date of the most recent accreditation failure.

Who Will Receive Email Notifications

MQSA Facility Portal notification emails will be sent to the following three facility contacts that are collected or verified during the annual inspection:

  1. Accreditation Contact  
  2. Most Responsible Individual
  3. Inspection Contact  

These contacts will be responsible for logging into the portal to retrieve and download the letter and/or certificate. Facilities are encouraged to verify that the contact names and email addresses provided to the FDA during the annual inspection are current and accurate.

If any information needs to be updated or verified, contact the CDRH MPRIS Helpdesk: cdrhmqrp@cdrh.fda.gov. To prevent important MQSA certification communications from going to a SPAM folder, it is recommended that facility contacts add fdsa_mqsa_certs@fda.hhs.gov to email contact lists.

How to Download a MQSA Certificate or Letter

Each portal notification email will include step-by-step instructions explaining how to access the portal and download the facility’s certificate and/or other documents. The process will generally involve the following:

Logging in to the MQSA Facility Portal using the facility's Facility ID and email address.

Completing an identity verification step via a one-time passcode sent to the facility's email address.

Downloading the latest certificate and/or letter directly from the portal.

Full step-by-step instructions will accompany every notification email received.

Important: Facilities are Still Required to Display a Printed MQSA Certificate

Although FDA will no longer mail printed certificates as of October 22, 2026, facilities are still legally required to prominently display a printed certificate on-site, as required under the Mammography Quality Standards Act. It is formally codified in the U.S. Code at 263b(b)(1)(A)(iii) and (b)(1)(B)(iii) and in its implementing regulations at 21 CFR § 900.11.

When a facility receives an email from the MQSA Facility Portal, which contains a certificate update, it will be the responsibility of each facility to download, print and display the MQSA certificate.

Reminder: Transition Period

During the transition, you may temporarily receive both a mailed certificate and a portal notification email for the same certificate. This overlap is expected until the portal system is fully implemented by October 22, 2026. 

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