May 09, 2018

FDA Releases Guidance on DBT Accreditation

Health care facilities must now apply to the American College of Radiology (ACR) or other approved Mammography Quality Standard Act (MQSA) accrediting bodies to accredit their digital breast tomosynthesis (DBT) units.

On April 6, 2018, the Food and Drug Administration (FDA), which administers MQSA, ended its Certificate Extension Program for DBT. The agency used certificate extension as a temporary way for facilities to fulfill MQSA requirements for operating DBT while its accrediting bodies developed standards for mandatory accreditation.

All four FDA MQSA accrediting bodies (the ACR, and the states of Arkansas, Iowa and Texas) have been approved to accredit DBT scanners. Each established its own procedures and transition mechanisms within the confines of the MQSA requirements for accreditation.

See MQSA Insights for detailed guidance from the FDA.