Radiation-Emitting Products

We perform a required quality assurance test more frequently than stated in the regulations. If the results of this test lie outside the regulatory action limits, must we take corrective actions based on this test or can we wait until the test is repeated at its regularly scheduled time?

Policy Guidance Help System logo

Regardless of when it is performed, if the facility documents that the results of a required quality assurance test lie outside the regulatory action limit, the facility must take the appropriate corrective action(s) within the specified regulatory time frame. 21 C.F.R. 900.12(e)(8).

Back to Quality Control Tests Other Than Annual

Back to Use of Test Results

Page Last Updated: 08/12/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.