The FDA’s MQSA attestation form is a written declaration mammography personnel use to document their initial training and clinical experience when the original certificates, transcripts, or procedure logs are no longer available. You download it from the FDA’s MQSA inspection resources page, complete it in the prescribed format, sign it under a false-statements warning, and file it with the facility’s personnel records for review at the next annual inspection. It is not submitted to the FDA.
When the Form Is Appropriate
Every mammography facility must keep documentation proving its personnel meet the qualification standards in 21 CFR 900.12, and inspectors review those records every year. The attestation exists for situations where primary documents are genuinely unobtainable: a former employer that shut down permanently, a fire or flood that destroyed archived files, or a training institution that closed without transferring its records.
Before you reach for the form, contact the original training institution, former supervisors, and any successor organization that may hold archived records. If duplicates exist anywhere, those go in the personnel file instead. The attestation is a last resort. Inspectors will ask why the originals are gone, so be prepared to explain the circumstances in writing alongside the form itself. Facilities that use the attestation without showing that recovery efforts failed risk inspection findings.
What to Put on the Form
The form is a structured written declaration. For each qualifying activity you are attesting to, provide as much of the following as you can:
- The institution or facility where the training, reading, interpreting, or other qualifying activity took place.
- The specific course, residency rotation, or continuing education program by name.
- The dates the activity occurred.
- The name of the supervising or responsible person who oversaw the work.
- The current facility’s address with zip code and the MQSA identification number from its certificate.
Write the details in the space provided and attach additional sheets if you need more room. Specifics matter. “Completed training in the 1990s” gives an inspector nothing to work with; “completed 240 interpretations under Dr. Jane Smith at Memorial Hospital between March and August 1993” can be cross-referenced against accreditation-body enrollment data, inspection databases, or the facility’s own historical files.
At the bottom you sign, date, and include your professional title. The declaration above the signature line states that the information is true and correct to the best of your knowledge and belief. It also warns that knowingly providing false information to a federal agency can result in criminal liability of up to a $11,000 fine and five years’ imprisonment, civil liability under the MQSA, or both.
Use the FDA’s version of the form, or a copy that matches its structure exactly. A free-form letter on office letterhead will not satisfy the requirement.
Qualification Minimums Your Narrative Must Account For
The attestation covers initial training and initial experience. What you write has to line up with the minimums for your personnel category.
Interpreting Physicians
An interpreting physician must have read or interpreted mammograms from at least 240 patients within a six-month period. For board-certified radiologists who passed the certifying exam at the first opportunity, that six-month window can fall anywhere in the last two years of residency. Physicians who were not board-certified at the first opportunity must have completed the 240 exams in the six months immediately before their qualification date. Residents who finished training in June 2014 or later can also draw the six-month period from anywhere in their last two years of residency.
Radiologic Technologists
Technologists qualified after April 28, 1999 need at least 40 hours of mammography-specific training covering breast anatomy and physiology, positioning and compression, quality assurance techniques, and imaging patients with breast implants. They must also complete 25 mammography examinations under the direct supervision of an MQSA-qualified individual. Before independently using any mammographic modality such as digital breast tomosynthesis, a technologist needs eight additional hours of modality-specific training.
Medical Physicists
A medical physicist qualified after April 28, 1999 needs a master’s degree or higher in a physical science, at least 20 semester hours of physics coursework, 20 contact hours of training in conducting mammography facility surveys, and experience surveying at least one facility and 10 mammography units. Physicists qualified before that date under interim regulations could meet a different track: a bachelor’s degree, 10 semester hours of physics, 40 contact hours of survey training, and experience with 20 units and one facility. All medical physicists must also hold board certification in diagnostic radiological physics or a related specialty, or be licensed or approved by a state. Eight hours of modality-specific training are required before surveying any mammographic modality the physicist was not initially trained on.
If your recollection falls short of these minimums, do not round up on the form. Attest to what actually happened and address the gap through requalification.
Filing and Retention
The completed attestation stays at the facility. It goes into the personnel qualification file for that staff member, alongside any other documentation that exists, and inspectors review it during the annual MQSA inspection. Expect them to look for both the attestation and a written explanation of the good-faith effort to retrieve the originals.
Facilities must retain personnel records for staff who have left for at least 24 months from the departure date, so the records remain available if an annual inspection falls in that window.
What False or Inflated Statements Cost
The attestation carries real legal weight. The warning printed on the form references the federal prohibition on making false statements to a government agency, which carries a maximum penalty of five years in prison and a fine. The civil money penalty for MQSA violations was adjusted for inflation to $22,263 per violation for penalties assessed on or after January 28, 2026. The FDA can also suspend or revoke a facility’s MQSA certificate, which prevents the facility from performing any mammography until the certificate is restored.
Accuracy matters more than completeness. The form asks for information to the best of your knowledge and belief, so an honest gap about exact dates is far less dangerous than inflating a number or inventing a supervisor’s name. The FDA may request additional information to verify what you declared, and a discrepancy between your attestation and any surviving records creates a much bigger problem than a shortfall you can cure through requalification.