Radiation-Emitting Products

What are acceptable forms of documentation for demonstrating that the technologist’s continuing experience requirement has been met?

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It will generally be sufficient if the technologist’s file contains a letter, table, or printout from each facility at which he or she performs mammography examinations, signed by a responsible facility official. The document should state that the technologist has performed a given number of examinations at that facility in a given time period.

It is assumed that these numbers are based upon more extensive records, such as facility logs, that can be reviewed if there are any questions. The facility logs themselves can then be used as documentation. However, the provision of summary letters, tables, or printouts will speed up the inspection process and rarely will the more detailed records be requested.

FDA recommends that these numbers be provided and updated on at least a quarterly basis. Facilities that plan to use the date of inspection as the end of the 24 months may wish to update them more frequently, perhaps monthly, to minimize the effort needed at the last minute in preparing for an inspection.

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Page Last Updated: 08/12/2014
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