DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 02-2

(FDA Web site: www.fda.gov)

Revised: December 2003

An Effective Defense Against Breast Cancer:

FDA’s Mammography Quality Standards Program

Mammography is the best

method for detecting breast

cancer in its earliest stages,

when the disease is most successfully treated and there are

more treatment options. Good

mammograms—images provided by well-maintained equipment and interpreted by welltrained professionals—can help

detect 85 percent to 90 percent

of breast cancers and can identify a tumor up to two years

before a lump can be felt.

Today, American women can

be sure that their mammograms

are of the highest quality thanks

to the Food and Drug Administration’s successful implementation of the Mammography

Quality Standards Act (MQSA)

of 1992. Under this law, all of

the over 9,100 mammography

facilities in the United States and

its territories are required to be

certified, inspected each year,

and meet the stringent standards

that are a prerequisite for topnotch, reliable mammograms.

Here are some of the requirements that the facilities must

meet in order to stay in business:

• All technologists who perform mammography must be

adequately trained and qualified

to operate the mammography

equipment, and must maintain

checked yearly at the time of

inspection.

• The mammographic images

must meet high standards of

quality for a facility to initially

become accredited and certified,

and must be reviewed by an

accrediting body every three

years.

• Women and their physicians

must be promptly and fully

informed in writing of the

mammography results so that

any follow-up tests or treatment

can begin in a timely manner.

To make certain that the

program brings the nation’s

women maximum benefits, the

FDA publishes a brochure for

consumers: Mammography

Today, which explains patients’

rights under the MQSA. Together with the National Institutes of Health, the FDA also

posts the addresses of all certified mammography facilities on

the Internet at www.fda.gov/cdrh/

mammography/certified.html and

makes them available through

the Cancer Information Service

hotline, (800) 4-CANCER (800-

422-6237).

For more information, refer to

the FDA’s MQSA Web site,

www.fda.gov/cdrh/

mammography.

their skills by performing an

average of 200 mammograms

every two years.

• All physicians who interpret

mammograms must meet specific initial and continuing

training, education, and experience requirements, including

interpreting at least 960

mammograms every two years.

• Mammography equipment

must be of appropriate design

and meet certain performance

characteristics, which are

Mammography Inspections

To ensure compliance with the

MQSA standards, the FDA trains its

own and state inspectors who

perform the annual inspections of

all mammography facilities. The

inspectors determine the radiation

dose used by each facility; assess

the image quality using a special

device that simulates the breast;

evaluate the quality of the facility’s

film processing; and review the

facility’s medical reports, medical

audits, and quality assurance and

control records. In addition, each

facility’s darkroom is tested for

unsafe light levels that may affect

image quality. The program

increased the number of facilities

that met the image quality standards

from 76 percent in 1994 to

99 percent in 2003.