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| 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                                                                                                                  | Adding the FFDM System to Your MQSA Certificate

Now that FDA has approved the General Electric (GE) Senographe 2000 D Full Field Digital Mammography (FFDM) system, what steps should you take before using this new technology for clinical examinations?  To put these steps in context, keep in mind that use of the FFDM system falls under MQSA.  Until FDA notifies you otherwise, the GE Senographe 2000 D system is exempt from MQSA accreditation requirements.  However, only MQSA screen-film certified facilities may lawfully use this system.

If your facility is already screen-film certified, contact Ruth Fischer, FDA's Chief of the Mammography Standards Branch (telephone 301/594-3332; fax 301/594-3306).  If your facility is not screen-film certified, apply to an FDA-approved accreditation body for screen-film accreditation.  FDA will issue your facility a certificate once the accreditation body tells the Agency it has accredited your facility.

Once you contact FDA for information on how to add the FFDM system to your current MQSA certification, you will be sent (a) a letter detailing the steps you need to take and (b) a document outlining the certification requirements for personnel and quality control you must meet.  For a preview of this information, go to the Digital Mammography section on the Facilities page of FDA's Mammography Program website.

Your facility should then submit an application providing the information FDA has requested.  Of note, you should also:
- Provide a list of all individuals who meet the personnel requirements under 900.12(a)(i) and currently perform mammography services on an FFDM system. Include whether their starting date in this modality was BEFORE or AFTER April 28, 1999.
- Provide a satisfactory FFDM equipment evaluation performed by a qualified medical physicist no more than six months before your application date.
- Follow the manufacturer's guidelines for quality assurance and quality control tests, as described in the manufacturer's manual.  Submit the results of tests performed during the first six months after beginning clinical examinations with the new FFDM unit.  Results should be submitted within one month of this six-month testing period. 

In reviewing your application, FDA may ask you for additional information before sending you a Letter of Acceptance or a Letter of Denial.  Once you receive a Letter of Acceptance, your FFDM system will be added to your certificate and you may begin to use it for clinical examinations.  If you receive a Letter of Denial, FDA will work with you to resolve the problems preventing your acceptance.

After your facility is approved to use the FFDM system, you must maintain accreditation status for at least one screen-film system.  In addition, your FFDM system is subject to an annual onsite MQSA inspection when your screen-film systems are inspected. |
| ***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 |