FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
| FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
  |
| Information
for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
 |
About Consumer Information
Search for a Certified Facility
Frequently Asked Questions
Other Resources
Articles
MQSA helps ensure that mammography is safe and reliable and that consumers receive uniformly high-quality services from facilities throughout the United States. In an effort to inform consumers about their rights under MQSA, FDA is pleased to announce its new consumer brochure, "Mammography Today: Questions and Answers for Patients on Being Informed Consumers." (PDF) (Text) (You are encouraged to print and distribute the brochure to help get this information out to all women.)
More than 9,000 FDA-certified facilities nationwide work to uphold the goal of the Mammography Quality Standards Act of 1992 as amended in 1998 (PDF): to ensure the safety and reliability of mammography and help detect breast cancer in its earliest, most treatable stages.
To legally perform mammography, a facility must be FDA certified and must post their certificate where patients can see it. To find a mammography facility in your area, click on "Search for a Certified Facility".
In reauthorizing MQSA, Congress mandated that facilities must send a report in lay language that summarizes the exam results to ALL patients within 30 days of the mammogram (patients who do not have a health care provider must also receive the mammographic report within 30 days). When the mammography report assessment is "Suspicious" or "Highly suggestive of malignancy," the lay summary results and recommended course of action must be communicated as soon as possible. This notification requirement went into effect on April 28, 1999.
The MQSA regulations also require that all facilities have a system place to address consumer complaints. FDA expects that most complaints can be resolved at the facility level. However, if a complaint cannot be resolved, the consumer should communicate with the facility's accreditation body. The name of the accreditation body is on the facility is on the facility's MQSA Certificate. More information about the consumer complaint mechanism may be found in the Consumer Complaint section of the Policy Guidance Help System.
FDA Consumer Mammography-related Articles:
"FDA Sets Higher Standards for Mammography," January-February 1999, provides general background information about mammography and the MQSA.
"Better Treatments Save More Lives," July-August 1999, addresses issues that range from mammography to specific types of treatments for, and additional information about, breast cancer.
Breast Implant Information
This site contains information about breast implants.
Mammography-related questions that are frequently asked of the Cancer Information Service (1-800-4-CANCER) as well as questions about Digital Mammography are included in the Frequently Asked Questions section.
The "Other Resources" area has more information about the National Cancer Institute, the Cancer Information Service, The National Women's Health Information Service, and other resources, including links to those sites.
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH