The role of Food and Drug Administration regulation of in vitro diagnosticdevices - Applications to genetics testing

The Food and Drug Administration (FDA) has been involved in the regulation of in vitro diagnostic devices (IVDs or laboratory tests) since the introdu ction of the Medical Device Amendments of 1976. IVDs developed as kits or s ystems intended for use in multiple laboratories require review by the FDA before being marketed to ensure appropriate performance and labeling. IVDs developed as in-house, or so-called "home-brew", tests or laboratory test s ervices are considered medical devices, but historically have not been subj ect to premarket review as a matter of enforcement discretion. FDA recently established a new regulatory paradigm for in-house tests based on classifi cation of the active ingredients or building blocks of these tests as analy te-specific reagents (ASRs). ASRs are exempt from premarket review but subj ect to both manufacturing and labeling controls. Currently, genetic tests a re received and reviewed by the FDA in the same manner as other in vitro di agnostic tests. The FDA currently is in the process of chartering a new gen etics advisory panel to provide the agency with outside expertise to deal w ith genetic testing issues. We are also continuing to work with other agenc ies within the Department of Health and Human Services to determine how we can cooperatively help foster this important new area of testing. (C) 1999 American Association for Clinical Chemistry.