MQSA certification is the federal certificate a mammography facility must hold to operate lawfully under the Mammography Quality Standards Act, and it requires accreditation by an FDA-approved accreditation body first. This service is for breast imaging center operators preparing for initial certification, renewal or quality remediation. Integral Healthcare Solutions (IHS) organizes the MQSA and accreditation evidence and drafts the policies; your clinical and physics staff own testing and interpretation.

Last reviewed: October 2026. FDA, eCFR, ACR and CMS pages checked on October 2, 2026; 21 CFR Part 900 read as of September 1, 2026.

What is MQSA certification?

The governing law is the Mammography Quality Standards Act, 42 U.S.C. 263b, implemented at 21 CFR Part 900. Certification is in 21 CFR 900.11 and the quality standards are in 21 CFR 900.12. Section 900.11(a) states: "After October 1, 1994, a certificate issued by FDA is required for lawful operation of all mammography facilities subject to the provisions of this subpart. To obtain a certificate from FDA, facilities are required to meet the quality standards in § 900.12 and to be accredited by an approved accreditation body or other entity as designated by FDA" (21 CFR 900.11).

So there are two steps. FDA describes them: a facility "must first be accredited by a federally approved private nonprofit or State accreditation body" and then obtains certification from FDA or a State Certifying Agency. FDA lists two approved accreditation bodies: the American College of Radiology (ACR) and the State of Arkansas Department of Health. FDA also states that a facility in a State approved as an accreditation body may be accredited by either the State body or ACR. Separately, FDA and the States of Illinois, Iowa, South Carolina and Texas act as certifying agencies that issue the MQSA certificate after accreditation (FDA, Facility Accreditation and Certification).

At ACR, mammography is its own application: "practice sites seeking accreditation in these modalities need to apply separately" (ACR, The Accreditation Process (Revised 8-4-2026)). Mammography also sits outside Medicare's advanced diagnostic imaging accreditation rule; CMS lists "diagnostic and screening mammography" among the exclusions (CMS).

Who needs it and what triggers it

• Every mammography facility subject to the subpart, since an FDA certificate "is required for lawful operation" (21 CFR 900.11(a)).
• A new facility. FDA states: "A provisional certificate is valid for up to six months" (FDA), and the regulation says it "will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process" (21 CFR 900.11(b)(2)(i)).
• A renewal. A fully certified facility holds "an MQSA certificate that is valid for three years" (FDA).
• The annual inspection: "The facility must be inspected at least annually by a certified MQSA inspector" (FDA).
• Quality remediation, when a facility needs its reporting, audit and records practices to match the quality standards in 21 CFR 900.12 (21 CFR 900.12).

How IHS helps

IHS works from 21 CFR 900.12 and the requirements of the accreditation body you choose. The process:

1. Gap assessment. IHS compares personnel, equipment and reporting records against 21 CFR 900.12 and the accreditation body's requirements, using questionnaires on staff, units and audits.
2. Document and evidence mapping. IHS crosswalks the answers to an inspection evidence index that shows the record behind each requirement and what is missing.
3. Drafting. IHS drafts policies for reporting, lay-letter timing, the medical outcomes audit and records, for your lead interpreting physician to review, change and approve.
4. Mock review. IHS runs a mock inspection review of the documents and lists the gaps.
5. Readiness support. IHS keeps the evidence index current for accreditation, certificate renewal and each annual inspection.

What you supply: personnel qualifications, physicist surveys, QC logs, and your radiologists, technologists and medical physicist.

The limit: IHS does not perform or review physics testing, QC or interpretation. The accreditation body accredits; FDA or the State Certifying Agency certifies; the MQSA inspector inspects. Your facility applies and hosts the inspection.

What to have ready

• Your choice of FDA-approved accreditation body: ACR, or the State of Arkansas body if your facility is in Arkansas (FDA).
• If you use ACR, a separate mammography application, since ACR requires sites to "apply separately" for mammography (ACR).
• For a new facility, a plan for the provisional certificate period, which is "valid for up to six months" (FDA) and is when you obtain the clinical images for accreditation (21 CFR 900.11(b)(2)(i)).
• Records that show you meet "the quality standards in § 900.12," which FDA certification requires (21 CFR 900.11(a)).
• A medical physicist arrangement. "Each facility shall have the services of a medical physicist available to survey mammography equipment and oversee the equipment-related quality assurance practices of the facility" (21 CFR 900.12(d)).
• A lay summary process and tracking log. Each facility must give "each patient a summary of the mammography report written in lay terms within 30 calendar days of the mammographic examination," including "an assessment of breast density" (21 CFR 900.12(c)(2)).
• A faster track for urgent results: if the assessment is "Suspicious" or "Highly Suggestive of Malignancy," the lay summary is due "within 7 calendar days of the final interpretation of the mammograms" (21 CFR 900.12(c)(2)).
• A medical outcomes audit program "to followup positive mammographic assessments and to correlate pathology results with the interpreting physician's findings" (21 CFR 900.12(f)).
• An inspection file ready at least once a year for the certified MQSA inspector (FDA).
• A renewal calendar keyed to the three-year certificate (FDA).

To go through the list with IHS, book the introductory call below.

How it compares

The options below come from FDA's and ACR's own pages. Which accreditation body fits depends on where your facility is and what it needs.

What it costs

FDA's inspection fee page states: "The FDA Mammography Quality Standards Act (MQSA) inspection fee for a mammography facility with one unit is $2,150 effective October 1, 2007." It adds: "The charge for each additional unit is $250" and "The fee for a follow-up inspection is $1,144" (FDA, Mammography Facility Inspection Fees, read October 2, 2026). The page's own effective date is 2007, so treat the figures as a published reference point, not a current quote; verify current fees with FDA.

ACR's "Fees and Payments" article lists mammography accreditation at "First unit with one module $2,000" (ACR Fees and Payments, read October 2, 2026). Verify current fees with ACR. The Arkansas accreditation body's fees were not among the pages we reviewed; fees depend on scope.

IHS scopes each engagement after a free introductory call.

What this is not

• IHS is not an accreditation body, FDA, a State Certifying Agency or an MQSA inspector, and does not grant, predict or influence their decisions.
• IHS does not contact, submit to or speak for your facility to any of them. IHS drafts; your facility applies and hosts the inspection.
• IHS does not perform physics surveys, QC testing or image interpretation, and this page is not legal or clinical advice.

Frequently asked questions

What is MQSA certification and how is it different from mammography accreditation?

Accreditation comes first: an FDA-approved accreditation body reviews the facility. Certification comes second: FDA or a State Certifying Agency issues the MQSA certificate that 21 CFR 900.11 requires for lawful operation. To get the certificate, a facility must meet the quality standards in 21 CFR 900.12 and be accredited.

Who are the FDA-approved mammography accreditation bodies?

FDA lists the American College of Radiology and the State of Arkansas Department of Health. Illinois, Iowa, South Carolina and Texas are State Certifying Agencies, not accreditation bodies.

How does a new breast imaging center get a provisional MQSA certificate?

Under 21 CFR 900.11(b)(2)(i), the provisional certificate lets a new facility perform mammography and obtain the clinical images it needs to complete accreditation. FDA states that a provisional certificate is valid for up to six months, cannot be renewed, and that a facility meeting certain criteria may apply for a one-time 90-day extension (21 CFR 900.11(b)(2)). FDA also states that a facility that has not completed accreditation before the provisional certificate expires must cease performing mammography. Accreditation work is planned around the six-month period.

How long is an MQSA certificate valid, and how often are facilities inspected?

FDA states that a full MQSA certificate is valid for three years. The facility must be inspected at least annually by a certified MQSA inspector.

What fee does FDA's inspection fee page list?

FDA's fee page lists $2,150 for a facility with one unit, $250 for each additional unit, and $1,144 for a follow-up inspection, effective October 1, 2007, invoiced after the inspection closes. For facilities in Illinois, Iowa, South Carolina and Texas the page lists the FDA portion as $548; the State charges separately. The page's own effective date is 2007, so treat the figures as a published reference point, not a current quote. Verify current fees with FDA before budgeting.

What must be in a mammography lay letter, and how fast must it go out?

21 CFR 900.12(c)(2) requires a summary of the mammography report written in lay terms within 30 calendar days of the examination, including an assessment of breast density. If the assessment is Suspicious or Highly Suggestive of Malignancy, the lay summary is due within 7 calendar days of the final interpretation.

What are the breast density notification requirements under MQSA?

The current text of 21 CFR 900.12(c)(2) requires the lay summary each patient receives to include, at a minimum, an assessment of breast density. Your interpreting physicians make the assessment; IHS drafts the reporting policy and tracking for them to approve.

What is a mammography medical outcomes audit and what must it include?

21 CFR 900.12(f) requires each facility to establish and maintain a medical outcomes audit program to follow up positive mammographic assessments and to correlate pathology results with the interpreting physician's findings.

Is mammography part of Medicare's advanced diagnostic imaging accreditation?

No. CMS lists diagnostic and screening mammography among the exclusions from the advanced diagnostic imaging accreditation requirement. Mammography facilities are governed by MQSA and 21 CFR Part 900.

Does IHS perform physics testing or deal with FDA for us?

No. Your medical physicist, technologists and radiologists own physics surveys, QC and interpretation. Your facility applies to the accreditation body and hosts the inspection; IHS drafts the policies and organizes the evidence behind them.