What was the objective of the ASR rule?
The ASR rule was designed to accomplish several policy objectives. One of the primary goals of the rule was to ensure the quality of the primary, active reagents of finished IVDs or LDTs. Another focus of the rule is the requirement for appropriate labeling to be appended to test results when ASRs are used by clinical laboratories in LDTs, so that healthcare users can understand when tests are being developed and validated by the laboratory and have not undergone FDA clearance or approval. 62 FR 62244. FDA adopted the approach of regulating most ASRs by means of general controls and exempting them from premarket notification requirements as the least burdensome approach. This approach relies primarily on cGMPs, medical device reporting, and labeling requirements to adequately control the risks associated with these devices. In addition, laboratories that develop tests using ASRs must be in compliance with the Clinical Laboratory Improvement Amendments (CLIA), 42 U.S.C. 263a 62 FR 62252
