Can experience obtained using investigational Full Field Digital Mammography (FFDM) units count toward the 8 hour mammographic modality training requirement?
Yes. Interpreting physicians who began interpreting FFDM images on investigational FFDM units (units that were used for research purposes before being approved by FDA for commercial distribution), are considered to have met the requirement for 8 hours of training with that mammographic modality. However, these interpreting physicians must either attest to or document that they were providing such services. Attestation should be done using an FDA attestation form (or equivalent) indicating where and when the FFDM interpretations were performed. An example of acceptable documentation would be a letter from an appropriate official at the facility where the interpretations were performed. For more information, see acceptable documents for interpreting physicians in the PGHS.
Interpreting physicians who begin working with non-investigational FFDM units after April 28, 1999 must document that they had 8 hours of training in that mammographic modality before independently interpreting FFDM examinations. Interpreting physicians must document this training using the same methods as those used to document other training (certificates, letters from the training provider, etc.). For more information see, acceptable documents for interpreting physicians in the Policy Guidance Help System (PGHS).