Radiation-Emitting Products

Accreditation Bodies

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 2006-2013 term for the FDA-approved accreditation bodies will expire on April 28, 2013. For the 2013-2020 term renewal, the FDA requires the accreditation bodies to implement full-field digital mammography (FFDM) softcopy image review as a condition for approval.

On January 10, 2013, the FDA approved the State of Arkansas accreditation body for another 7-year term with an expiration date of April 28, 2020.

On April 3, 2013, the FDA approved the State of Iowa accreditation body for another 7-year term with an expiration date of April 28, 2020.

On April 18, 2013, FDA extended the State of Texas (STX) accreditation body's current term of approval for one year until April 28, 2014. Once STX fully implements its clinical image soft copy review process and receives final approval, FDA will grant STX a full seven year term.

On April 25, 2013, FDA extended the American College of Radiology (ACR) accreditation body's current term of approval for one year until April 28, 2014. Once ACR fully implements its soft copy review process and receives final approval, FDA will grant ACR a full seven year term.

To be FDA-certified, a facility must first apply to, and become accredited by, an FDA-approved accreditation body. Currently these are:

To be accredited by the States of Arkansas, Iowa, or Texas, a facility must be located in that accreditation body's state. Under MQSA regulations, a facility located in a state with a 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.

Page Last Updated: 10/08/2014
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