In the final regulations, FDA has focused primarily on the performance aspects of the quality control testing, in contrast to the interim regulations, which included a complete set of procedures through referencing the ACR manuals. As a result, the agency has refrained from providing extensive detailed requirements or descriptions of test procedures.
The regulations specify the required QC test criteria and outcomes (tests to be done, frequency, and especially the action limits to be met). FDA’s approach gives facilities the flexibility to use procedures that best enable them to meet the requirements. Facilities may continue to use procedures found in current manuals as long as they are consistent with the final regulations. Besides the test methodologies, the facilities can also use their own formats or those of appropriate manuals (e.g., charts, tables) for documenting test results.