States as Certifiers: Who They Are and What They Do
States as Certifiers (also known as SACs) are entities approved by the Food and Drug Administration (FDA) to carry out certification, inspection, and compliance activities, and have the same authority as the FDA to regulate mammography facilities located within their states. SACs ensure that facilities in their states adhere to the Mammography Quality Standards Act (MQSA) regulations as well as any state regulations related to mammography facilities, which can differ from FDA's and be more stringent.
The primary responsibilities delegated under the SAC program include:
- Issuance, renewal, denial, suspension, and revocation of certificates to non-federal mammography facilities within the state (note that a certificate issued by FDA or a SAC is required for lawful operation of a mammography facility)
- Annual facility inspections (except for federal facilities which are inspected by FDA)
- Compliance actions for any MQSA inspection findings.
Currently, the four FDA-approved SACs are:
- Illinois (349 certified facilities - SAC since 2004)
- Iowa (141 certified facilities – SAC since 2004)
- South Carolina (111 certified facilities – SAC since 2005)
- Texas (562 certified facilities – SAC since 2008)
The SAC programs are usually operated by the States' radiological health programs and the inspectors are MQSA qualified state employees who have well-established working relationships with the facilities they inspect. They are trained to the same standards as all FDA MQSA qualified inspectors, which includes comprehensive training conducted at FDA headquarters.
Each SAC is assigned an FDA liaison. The liaison provides direction and answers questions that may arise. The liaison also performs weekly, quarterly, and annual oversight regarding the SAC's certification, inspection, and compliance activity performance. The SAC's yearly evaluation determines if there are major deficiencies in the SAC's performance that, if not corrected, would warrant withdrawal of the SAC's approval, or minor deficiencies that require corrective action.
SACs are also responsible for the collection of fees. These fees are determined by the SAC and are based on the costs of providing certification and yearly MQSA inspections. A portion of SAC inspection fees is collected by FDA, because SACs use FDA data systems and their inspectors are trained and equipped by FDA.