RAC US Exam Question No 13

Question No 13:

A manufacturing process requires purified water to produce several finished Class I exempt and Class II 510(k) medical devices. The water is tested monthly by quality control (QC). Since results have consistently been within specifications, the product is sent to distributors before QC results are final. Over the past six months quality test results have been getting closer to the specification limit. Internal review determined that QC testing should now take place weekly. This information should be provided to FDA through:

A. A post approval study report
B. A medical device report
C. This information does not need to be submitted
D. An Annual Report

Answer: C