Under the Mammography Quality Standards Act (MQSA), and Per Title 21, Code of Federal Regulations, §900.3(g), the Food and Drug Administration (FDA) approves a private non-profit organization or a State agency to serve as an accreditation body for one 7-year term at a time. The current 2020-2027 term for the FDA-approved accreditation bodies will expire on April 28, 2027. On June 2, 2020, the FDA approved the State of Arkansas accreditation body for another 7-year term with an expiration date of April 28, 2027.
On July 28, 2020, the FDA approved the STX accreditation body for another term with an expiration date of April 28, 2027.
On June 11, 2020, the FDA approved the ACR accreditation body for another term with an expiration date of April 28, 2027.
To be FDA-certified, a facility must first apply to, and become accredited by, an FDA-approved accreditation body. Currently these are:
- American College of Radiology(ACR)
Mammography Accreditation Program
- Arkansas Department of Health
Radiation Control Section
- Texas Department of State Health Services
Radiation Control Program
To be accredited by the States of Arkansas, or Texas, a facility must be located in that accreditation body's state. Under MQSA regulations, a facility located in a state with an FDA-approved accreditation body may be accredited either by the state or by the ACR. However, if state law requires every facility to have state accreditation or state certification, facilities must satisfy those regulations. These state requirements are independent of MQSA.
For more information about Accreditation and Certification, consult the Policy Guidance Help System.