An interpreting physician has been practicing under FDA’s interim regulations and met all of the initial and continuing requirements under those regulations. Will he or she have to go back and get additional mammography training to meet the requirements after April 28, 1999?
No, the interpreting physician will not have to obtain additional initial training to continue reading and interpreting mammograms after April 28, 1999. However, after April 28, 1999, if the physician wants to begin reading and interpreting mammograms produced by a mammographic modality (such as digital mammography) in which he or she has not been trained, the physician will need to get at least 8 hours of training in the new mammographic modality. 21 C.F.R. 900.12(a)(1)(ii)(B). For continuing medical education, only category I may be counted toward meeting the requirement after April 28, 1999. 21 C.F.R. 900.12(a)(1)(ii)(B).