I wish to count the time spent performing these mammograms toward the 40 hour requirement. All of the examinations were performed on a full field digital mammographic unit.
In previously issued guidance, we stated that training programs or facilities may include the actual time spent performing supervised examinations toward the 40 hour total. As guidance, however, FDA recommends that no more than 12.5 hours of the required 40 come from performing examinations. Once you complete the 25 mammograms, you are qualified to perform screen film mammograms independently but not necessarily FFDM mammograms. In order for you to also perform FFDM mammograms independently, the training program or mammography facility will have to supply you with additional documentation showing that at least eight hours of experience/training was in FFDM. 900.12(a)(2)(iii)(E).