900.12(a)(1)(ii)(C): Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality.
Copies of certificates earned or other documentation from the training provider will suffice for the new mammographic modality training. FDA will continue to accept a limited form of attestation for CME received after October 1, 1994, in certain cases.
- There is a requirement for 8 hours of training for any new mammographic modality before an interpreting physician may begin independently interpreting mammograms produced by this new mammographic modality. If the physician did not have this training during residency, would it have to be category I continuing education? What about applications training from the manufacturer of the new mammographic modality?
- What are examples of mammographic modalities? What types of training would be acceptable as training in new mammographic modalities?
- Some personnel may receive some training in full-field digital mammography as part of their initial qualifications. In addition to counting toward their initial requirements, can this training also be applied to the 8-hour mammographic modality training requirement?
- Some personnel may receive continuing medical education (CME/CEU) in full-field digital mammography as part of the CME/CEU requirement. Can they also use this toward meeting the initial 8-hour mammographic modality training requirement?
- Can experience obtained using investigational Full Field Digital Mammography (FFDM) units count toward the 8 hour mammographic modality training requirement?
- Are there any requirements for the content of the FFDM training and are they affected in any way by changes in the field such as the publication of a new QA manual, FDA approval of soft copy interpretation, or the introduction of a new model of FFDM by a manufacturer?
- What qualifications have to be met by the individual providing the training?
- I'm an interpreting physician and worked with stereotactic biopsy systems with digital image receptors prior to 4/28/99. Am I considered to have met the 8 hours of training specific to FFDM??
- I'm an interpreting physician and received training in digital image receptors used for stereotactic biopsy. Can that training count toward the 8 hours of training specific to FFDM?
- We do not have an FFDM unit at our facility, however, some of our personnel use an FFDM unit at another facility. Are we responsible for maintaining documentation showing that these people have received their initial training in the new mammographic modality?
- I am a physician who wishes to become intially qualified as an interpreting physician. I have completed my three months of intial mammography training in screen-film mammography and read 240 mammograms during the last six months of the residency program under direct supervision but all of the examinations were performed on a FFDM unit. Does this satisfy the regulatory requirement?
- I am the physician in question 11. Once I have completed my initial requirements, can I independently read both screen-film and FFDM examinations?