Oversight of Laboratory Developed Tests

Executive Summary

For several years, FDA officials have indicated they are reconsidering the current exemption from medical device legislative authority for in-house developed laboratory tests. This exempts most laboratory-developed tests from FDA oversight and regulation. ACLA has met with FDA on several occasions and as a member of the FDA IVD Professional Roundtable to explore the feasibility of crafting a proposed definition of "high risk" testing. ACLA is continuing this dialogue with the FDA.

Background

In the past, the FDA's major regulatory efforts with regard to laboratory testing have involved "analyte specific reagents" (ASRs) which are the active components in many laboratory-developed tests, especially genetic tests. In the ASR regulation, issued in November 1997, the FDA stated that most ASRs would be considered Class I and therefore exempt from pre-market approval or clearance by the FDA. The ASR rule did indicate that some tests for contagious diseases, such as tuberculosis or HIV, would be considered Class III, and thus subject to FDA pre-market clearance or approval.

In more recent statements, FDA officials have indicated that they are concerned about the lack of oversight of in-house developed laboratory tests and are considering a revision of the ASR rule. While we have seen no draft proposals, statements from the FDA indicate they are considering a revision of the ASR rule that could require laboratories to obtain FDA approval or clearance for certain "high risk" laboratory-developed tests. At this point, "high risk" has not been defined. While much of the discussion has focused on genetic testing, FDA officials have indicated that their concerns are not limited to genetic testing.