FDA has extended our certification to include our FFDM unit. Are there any special requirements we need to be aware of?
Once you receive FDA’s Letter of Acceptance, you may lawfully begin using the FFDM unit for clinical examinations. However, the extension is contingent upon you meeting the following conditions while using the FFDM unit:
- Maintain accreditation status for at least one mammography unit to which the FFDM unit is linked. During the annual onsite MQSA inspection of the certified facility, all units including this FFDM unit will be evaluated.
- Upon completion of the first semi-annual quality control tests, provide FDA with the results of the weekly, monthly, quarterly, and semi-annual quality control tests outlined in the manufacturer’s quality control manual. The report needs to include the results of the required QC tests for the Soft Copy Display system.
- Send quality control test results to FDA no later than nine months after starting clinical examinations using the FFDM unit.
- Have the FFDM unit surveyed annually by an MQSA qualified medical physicist.