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  1. MQSA Insights

Mammography at the FDA: Beyond MQSA

At the Food and Drug Administration (FDA), mammography is addressed by more than just the Mammography Quality Standards Act (MQSA) program. While the Division of Mammography Quality Standards (DMQS) oversees the quality assurance of mammography facilities, other components of the FDA assure the safety and effectiveness of mammography units and evaluate other breast imaging and diagnostic technologies.  These functions are implemented through the collaboration of several different components of the FDA; they also complement other functions of the FDA in which DMQS mammography experts participate. 

The FDA is divided into Centers for various product types: foods, drugs, medical devices, biologics, tobacco products, and veterinary food and medicine.  Within the Center for Devices and Radiological Health (CDRH), there is an Office of In Vitro Diagnostics and Radiological Health (OIR), which reviews products such as medical laboratory equipment, consumer medical tests, and radiation-emitting medical and consumer products.  OIR also implements the MQSA. 

The mammography-related functions of the FDA are performed primarily by two separate but "sister" divisions of OIR – DMQS which implements MQSA regulation of facilities, and the Division of Radiological Health (DRH) which regulates manufacturers of mammography units, display devices, and related software, among other radiological medical devices.  CDRH (including DMQS and DRH) and the other product-based FDA Centers also work closely with the FDA's Office of Regulatory Affairs (ORA), which has regional or "field" offices throughout the country that perform inspections of many mammography facilities as well as manufacturing facilities for foods, pharmaceuticals, medical devices and other products.

Of the four branches of DRH, DMQS works most closely with the Mammography, Ultrasound and Imaging Software Branch, which is responsible for the premarket review of new breast imaging devices and computer-aided detection/diagnosis software, post-market surveillance of adverse events, and for taking compliance actions when problems are discovered with mammography equipment already on the market. (Other branches of DRH cover other radiology and imaging devices, such as X-ray, CT scan, MRI, and nuclear medicine imaging equipment, as well as radiation therapy equipment and some nonmedical radiation-emitting products such as microwave ovens, nonmedical lasers, and tanning devices.) 

CDRH takes a "total product life cycle" approach to the products it oversees, including responsibilities related to the premarket and postmarket review of devices and the monitoring of device manufacturers' compliance with regulations.  For medical devices, premarket review addresses FDA clearance or approval of new devices before they can be sold in the US; postmarket surveillance includes continued review of safety and effectiveness data for devices which are already on the market; and compliance addresses the need for companies to maintain good manufacturing practices which assure the continued safety and quality of their products.  For mammography, MQSA applies to each facility that performs mammograms, and the compliance process assures that facilities continue to meet the required quality standards in areas such as personnel qualifications, equipment testing, and communicating results to patients.

Thus, DMQS and other components of the FDA have many mutually beneficial interactions to advance public health:

  • DMQS and ORA work closely together to monitor the results of mammography facility inspections, and to communicate with facilities which need to take corrective action due to noncompliance.
  • Medical officers, compliance officers, and medical physicists from DMQS are consulted by DRH during its review of new breast imaging devices and relevant software, and for postmarket and compliance actions which involve a breast imaging device.  This interaction helps alert DRH reviewers to MQSA requirements which are unique to mammography, in addition to the typical range of premarket safety and effectiveness questions which apply to all medical devices. 
  • Similarly, DMQS personnel are consulted by other units of the FDA which review medical products related to breast health and collaborate with the CDRH Office of Science and Engineering Laboratories for its regulatory science research related to breast imaging.
  • DMQS personnel work with colleagues in the Office of Communications and the Office of Media Affairs to provide input into FDA public communications, such as Consumer Updates and responses to media requests, when they relate to breast health.
  • DMQS medical officers and medical physicists assist in reviewing breast-related research projects submitted to the FDA Office of Women's Health to help determine how to best allocate funds to support these important areas of research.

In summary, from the review of new mammography units and other devices, to postmarket surveillance of these devices, to mammography facility certification, to compliance for both facilities and manufacturers, to public communication about breast health, to the promotion of related research, DMQS and our colleagues throughout the FDA work in concert to promote and ensure quality imaging and breast health.  We in DMQS are proud to play a part in the FDA's broader responsibility to assure the safety and effectiveness of the nation's medical equipment, which dovetails nicely with our primary responsibility to ensure quality mammography for women across the nation.

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