Under the interim regulations, FDA had a continuing experience policy stating that once interpreting physicians requalified to work independently, they were exempt from an adverse finding for this requirement for a period of six months after the requalification date. Will this policy continue and will it be expanded under the final regulations to include radiologic technologists?
Yes, to both questions. Upon completing the continuing experience requalification process, interpreting physicians and radiologic technologists will be exempt from an adverse finding for the continuing experience requirement for a period of six months after completing the requalification process. Those not fully meeting the continuing experience requirement by the end of the six-month deadline period may have to repeat the requalification process.
FDA allows interpreting physicians and radiologic technologists this six-month period so they can provide mammography services independently without being subject to multiple adverse findings related to their continuing experience. Without this six-month period, individuals who work at more than one facility could be the subject of such adverse findings at each facility that employs them, even though they have complied with the requalification process. Personnel who are in either the requalification process or in this six month period should provide written documentation of their status to all the facilities at which they provide mammography services in order to preclude further inspection problems. Medical physicists are treated differently because their requalification process causes them to fully meet their continuing experience requirement. A similar approach for the continuing education requirement is also not needed because the continuing education requalification process causes all personnel to fully meet this requirement.