|                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Volume 7, Issue 2                                                                                                                                                                                                                                                                                                                                                                                                                                                           |   | Spring 2000 |
| In This Issue...Adding the FFDM System to Your MQSA CertificateMammography Today Update!From the DirectorNew Mammography Program WebsiteEnsuring High-Quality Mammography:  Spotlight on InspectorsInspection Fee Payment ReminderRecognizing Inspectors' ServiceFDA Addresses Consumer IssuesQ&AAccreditation, Certification, and Commercial Products                                                                                                                  | From the Director

This newsletter issue marks a turning point on many levels. We have "gone electronic." Heralding another transition to technology is our increased use of the Mammography ListServ, which allows us to contact all subscribers to the list. Information available through the ListServ includes newsletter highlights, which link you directly to the newsletter article you select, and other MQSA news and alerts. (Subscribe to the Mammography list.)

Beyond these electronic advances, however, Mammography Matters has reached a new level in its mission. The final MQSA regulations are in place, MQSA inspections are being conducted under the new regulations, and a mechanism to extend certification to digital mammography units has been developed. In sum, many of the goals FDA set to ensure high-quality mammography for women have been met — and this newsletter has helped inform you of our steps toward meeting those goals.

As new objectives and challenges emerge in our continued effort to support the mission of MQSA, we invite you to participate in molding the content of future issues of this newsletter. What aspects of MQSA would you like to read about? What do you think others in the mammography community should know?  Together, let's be sure that what we communicate provides the information you need. Please contact our editor, Evelyn Wandell ([email protected]) with your feedback.

Spotlight on Inspectors

This past January, we reached the five-year anniversary of the beginning of MQSA inspections. FDA has been honoring inspectors who share this anniversary in years of service. What an appropriate time to highlight two inspectors who work day-to-day with facilities to ensure high-quality mammography (see story).

Tom Garvin, a veteran FDA inspector from Milwaukee, Wisconsin, went through the Agency's training program in 1994, after working with FDA's radiological health programs since the 1970s. Mary James, of Columbia, South Carolina, became a State inspector last July, building on six years of work using her certifications in mammography and quality management. With different backgrounds, but a shared dedication to enabling facilities in their delivery of quality mammography services, both inspectors are to be commended for their services.

Digital Mammography for Clinical Exams

In our last issue, we announced FDA approval of the GE Senographe 2000 D Full Field Digital Mammography (FFDM) system. Before facilities use this system, however, they must be MQSA screen-film certified; if certified, they should then submit an application to FDA to add the FFDM system to their MQSA certification. The application will require facilities to demonstrate that they meet personnel and quality control requirements. If needed, FDA may ask a facility for additional information before granting approval to use this technology for clinical examinations. Please see Adding the FFDM System to Your MQSA Certificate for further details.

Consumer Concerns

Finally, we are interested in sharing stories on occasion that highlight how facilities handle their consumers' concerns. If you have a story to share that may be of help and interest to other facilities-also likely to be dealing with a similar situation-please e-mail Evelyn Wandell at epw@cdrh. fda.gov.

John L. McCrohan, M.S.Director, Division of Mammography Quality and Radiation Programs |
| ***Facility Hotline***Call the facility telephone hotline (1-800-838-7715) or fax (410-290-6351) for more information about FDA certification or inspections.                                                                                                                                                                                                                                                                                                               |
| *Mammography Matters*is a quarterly publication of the Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiological Health (CDRH), Food and Drug Administration. Its purpose is to help mammography facilities comply with the requirements of the Mammography Quality Standards Act of 1992. Comments should be addressed to: *Mammography Matters* | FDA/CDRH (HFZ-240) | 1350 Piccard Drive | Rockville, MD 20850Fax 301-594-3306 |