What information will we need to provide in our request for FFDM certification extension?
You need to provide a list of all personnel who began working in (i.e., interpreting, performing, and surveying) the FFDM mammographic modality prior to April 28, 1999 (if any) as well as a list of personnel who began or will begin working in the FFDM mammographic modality after April 28, 1999. In addition, you need to provide a satisfactory FFDM mammography equipment evaluation (including an evaluation of the Soft Copy Display system, if applicable) performed by a qualified medical physicist within 6 months prior to the date of your application.
You will also need to follow the manufacturer's guidelines for quality assurance and quality control tests as described by the manufacturer's manual. No later than 9 months after you begin clinical examinations using the FFDM unit, you must submit to the FDA the results of the tests performed during the first 6 months after beginning clinical FFDM examinations.