Description
FDA has developed this Small Entity Compliance Guide (SECG) to explain the actions a small entity is required to take to comply with the MQSA rule and its implementing regulations. The March 2023 MQSA rule modernized mammography regulations and specifies that the mammography report given to patients specifies if the patient has dense or non dense breast tissue and includes a prescribed paragraph on the significance of breast density. The SECG also includes policy and recommendations previously found in the Policy Guidance Help System.
Scope & Applicability
Product Classes
5special purpose x-ray system
supplement for mammography systems
subject to same standards as stationary facilities
Devices used in studies under 21 CFR part 812
Modality not regulated under MQSA
Stakeholders
10hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician
members of the NMQAAC
members of the NMQAAC
members of the NMQAAC
members of the NMQAAC
responsible for maintaining monitoring data
Individual performing tasks under direct supervision
person performing the annual MQSA inspection
designated individual responsible for notifying IPs of audit results
The provider to whom the mammography report must be sent.
Regulatory Context
Attributes
10standards for clinical image quality; Standard evaluated by accreditation bodies
Requirement for supervisor presence and observation
Measurement of ongoing training (CEU)
A qualification requirement for interpreting physicians.
metric required in the medical outcomes audit
metric required in the medical outcomes audit
metric required in the medical outcomes audit
A final assessment category for mammography findings.
A final assessment category for mammography findings.
One of the required overall assessments in the mammography report.
Identified Hazards
Hazards
2trigger for AMR
threshold for requiring patient notification
Related CFR Sections (7)
- 21CFR900.14§ 900.14 Suspension or revocation of certificates.
(a) Except as provided in paragraph (b) of this section, FDA may suspend or revoke a certificate if FDA finds, after providing the owner or operator of the facility with notice and opportunity for a hearing in accordance with part 16 of this chapter , that the facility, owner, operator, or any emploRead full regulation →
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
- 21CFR900.12§ 900.12 Quality standards.
(a) Personnel. The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities:Read full regulation →
- 21CFR900.2§ 900.2 Definitions.
The following definitions apply to subparts A , B , and C of this part :Read full regulation →
- 21CFR900.11§ 900.11 Requirements for certification.
(a) General. 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 appRead full regulation →
- 21CFR900.4§ 900.4 Standards for accreditation bodies.
(a) Code of conduct and general responsibilities. The accreditation body shall accept the following responsibilities in order to ensure safe and accurate mammography at the facilities it accredits and shall perform these responsibilities in a manner that ensures the integrity and impartiality of accRead full regulation →
- 21CFR900.21§ 900.21 Application for approval as a certification agency.
(a) Eligibility. State agencies may apply for approval as a certification agency if they have standards at least as stringent as those of § 900.12 , qualified personnel, adequate resources to carry out the States as Certifiers' responsibilities, and the authority to enter into a legal agreement withRead full regulation →
Related Warning Letters (5)
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-12
Investigational Review Board (IRB)
Nobles Medical Technology II, Inc.
- 2023-04-04
CGMP/QSR/Medical Devices/Adulterated
Synovo Production, Inc.
- 2020-04-07
Investigational Device Exemptions (Clinical Investigator)
Kennedy, Philip R.
See Also (8)
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Status: Final)
- Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (Status: Final)
- Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for Industry (Status: Final)