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?

The 8 hours of initial training related to FFDM should include practical (hands-on) training in any aspects of the use of such systems in the interpreting physician’s area of responsibility that are unique to the FFDM system (such as computer manipulation of images). The remainder of the 8 hours, if any, can be didactic or practical training related to any aspect of FFDM. The instruction must be provided by a qualified instructor. If this training is category I CME, such training can also be counted towards the interpreting physician’s continuing education requirement.

 

FDA strongly recommends that interpreting physicians whose 8 hours of FFDM training did not include any training in soft copy interpretation, obtain such practical training under a qualified instructor before beginning to independently manipulate and interpret soft copy images. If category I CME, such training can also be counted towards the interpreting physician’s continuing education requirement.

 

For other changes that can occur in the field, such as introduction of a new quality control manual by the manufacturer or the introduction of a new model of a FFDM unit, the same general principle as described above with “soft copy” interpretation should be followed. If the new manual or model introduces new unique features to an FFDM system that fall into the interpreting physician’s area of responsibility, practical training under a qualified instructor on those features should be included in the training of any interpreting physician who has not already met the 8 hour requirement. Interpreting physicians who have previously met this requirement should also receive training in the new unique features under a qualified instructor before beginning to use them independently. If category I CME, such training can also be counted towards the interpreting physician’s continuing education requirement.