What are examples of mammographic modalities? What types of training would be acceptable as training in new mammographic modalities?

The term mammographic modality refers to a technology for radiography of the breast. 21 C.F.R. 900.2(z). Examples of long available mammographic modalities are full field digital mammography (FFDM) and screen-film mammography. An example of a relatively new mammographic modality is digital breast tomosynthesis (DBT). Personnel whose training pertained solely to FFDM would be required to obtain 8 hours of training in DBT, if they are to begin providing services or interpretations using this mammographic modality. However, if those personnel gained their experience using investigational DBT units (units that were used for research purposes before being approved by FDA for commercial distribution), they are considered to have met the 8 hour requirement. 

 

New mammographic modality training can be in many forms, including, but not limited to, residency training, special training courses, continuing medical education, and training provided by the manufacturer. For interpreting physicians, this does not have to be category I continuing medical education.

Table of Contents

Index

Glossary

-Search-

Back