What is FDA’s FFDM review process?
Upon receipt of the completed FFDM package, FDA will review the documentation. If the application is complete and satisfactory, FDA grants an approval to the facility and sends a Letter of Acceptance. For an incomplete or unsatisfactory application, FDA will send a Letter of Denial or request additional information from the facility. FDA will then work with the facility and/or the medical physicist to resolve discrepancies and complete the application process.