The answer is outlined below and depends on whether there is an accreditation body that accredits your FFDM unit and whether you are adding the FFDM unit to an already-certified facility.
- If your facility is already certified AND there isn’t an approved accreditation body (AB) for your FFDM unit then you need to request that FDA extend your certification to cover the FFDM unit. Additional details are outlined in questions 2-4. You cannot use this FFDM unit on patients until you receive a Letter of Acceptance from the FDA.
- If your facility is already certified AND there is an approved AB for your FFDM unit then you may begin examining patients with the new unit ONLY AFTER the medical physicist indicates that the Mammography Equipment Evaluation (MEE) has passed AND the facility has sent the complete application for the new unit (with the MEE results) to the AB. Once approved, the AB will notify the FDA (or State Certifying Agency) within two business days that an accreditation application has been accepted for the new unit. You are not required to wait for a response from the AB to begin clinical use of the new unit since you are already operating with a current MQSA certificate. However, the Centers for Medicare and Medicaid Services (CMS) will not reimburse for examinations performed on an FFDM unit until the FDA has received notification that you have applied for accreditation of your new FFDM unit. In order to ensure appropriate reimbursement, we recommend that MQSA-certified facilities do the following before using their new FFDM unit to examine patients: Fax or send the application materials with the MEE results to the accreditation body as soon as possible, and after three business days, contact the accreditation body to confirm that the new unit information was sent to the FDA.
- If you are not already certified AND there is an approved accreditation body for your FFDM unit then you must follow and satisfactorily complete all the AB’s procedures for accrediting that unit. 21 C.F.R. 900.11. Because your facility is not already certified, you CANNOT use the unit to examine patients until you receive your MQSA certificate or interim notice from the FDA or the State Certifying Agency. 21 C.F.R. 900.11.
- If you are not already certified AND there isn’t an approved AB for your FFDM unit then you need to either obtain accreditation and certification for a different mammography unit OR become linked to an already certified facility. You can then proceed with Step 1.