Application Submission

All applications with fees are to be sent to this address:

Department of State Health Services
Cash Receipts Branch – MC 2003
P.O. Box 149347
Austin, TX 78714-9347

To minimize delays in processing renewal and amendment applications, submit documents to MammographyBranch@dshs.texas.gov.

Legislation

In 1993, the Texas Legislature passed House Bill 63 which amended the Texas Health and Safety Code requiring that Texas apply to become an Accrediting Body and to apply to the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Division of Mammography Quality Radiation Program (DMQRP) to be a Certifying Agency. 

On September 1, 2008, the State of Texas was approved as a Certifying Agency by the U.S. Food and Drug Administration (FDA) and carries out the certification functions for all facilities located within Texas.

To legally perform mammography in Texas, a facility must be certified. To obtain a certification, the facility must apply for and achieve accreditation by an FDA-approved accreditation body and meet applicable requirements established by the Mammography Quality Standards Act (MQSA) and the accreditation body of choice. 

All facilities that perform interventional breast radiography must apply for and receive a Certificate of Mammography Systems. Machines used exclusively for interventional breast radiography are not required to be accredited by an FDA-approved accrediting body.

Each new mammography facility will be inspected within 60 days of receiving a Certified Mammography Facility Certificate. After the initial inspection, each mammography facility will undergo an annual inspection by an FDA-certified MQSA inspector.

Helpful Links

• FDA Mammography Quality Standards Act Program
• FDA Small Entity Compliance Guide
• American College of Radiology Mammography Accreditation