Mammography Facilities, Standards, and Lay Summaries for Patients

OMB 0910-0309

OMB 0910-0309

Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA approved accreditation body (AB). This requires undergoing a review of their clinical images and providing the AB with information showing that they meet the equipment, personnel, quality assurance and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer compliant mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis.

The latest form for Mammography Facilities, Standards, and Lay Summaries for Patients expires 2022-10-31 and can be found here.


© 2021 OMB.report | Privacy Policy