900.12(a)(3)(iii)(C): Before a medical physicist may begin independently performing mammographic surveys of a new mammographic modality, that is, a mammographic modality other than one for which the physicist received training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist must receive at least 8 hours of training in surveying units of 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. (see Attestation - Acceptable Uses for Personnel Requirements)
- 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 new modality training requirement?
- Some personnel may receive continuing medical education (CME) in full-field digital mammography as part of the CME requirement. Can they also use this toward meeting the initial 8-hour new 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 the 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 FFDM model by a manufacturer?
- What qualifications have to be met by the individual providing the training?
- I'm a medical physicist and surveyed stereotactic biopsy systems with digital image receptors prior to 4/28/99. Does that exempt me from having to obtain 8 hours of training specific to FFDM?
- I'm a medical physicist 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 physicist who wishes to become initially qualified as a medical physicist. I completed my 20 contact hours of initial mammography training in screen-film mammography and performed one facility and ten unit surveys under direct supervision but all the surveys were performed in a full field digital mammographic facility. Does this satisfy the regulatory requirement?
I am a physicist who wishes to become initially qualified as a medical physicist. I completed 10 contact hours of initial mammography training in screen-film mammography and performed one facility and ten unit surveys under direct supervision. I wish to count the time spent performing these surveys toward the 20 hour requirement. All of the surveys were performed in a full field digital mammographic facility. Is this acceptable and am I qualified to independently perform both screen-film and FFDM surveys?