FDA Releases Mammography Report
Device Regulation Alert: Safety, Compliance and Reimbursement News, April 7, 2008
On March 20, the FDA issued its Mammography Facility Adverse Event and Action Report, which is mandated by the Mammography Quality Standards Act.
The report is based on information gathered from:
- Federal, state, and territorial agencies
- The American College of Radiology
- OIG
- CMS
- Accrediting organizations
- Certification agencies
- FDA offices such as the Division of Mammography Quality and Radiation Program and the Office of Criminal Investigations
The report summarizes adverse events and penalties involving mammography facilities. Two facilities lost accreditation, while three others facilities had quality problems. The report also listed three state-level adverse events.
No Medicare/Medicaid violations were charged to mammography facilities and only one certifying agency action was taken.
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