FDA ISSUES DRAFT GUIDANCES FOR MEDICAL TESTS AND REAGENTS

The FDA issued two draft regulatory guidances Wednesday: one on analyte specific reagents (ASRs) and one on in vitro diagnostic multivariate index assays (IVDMIAs).

The FDA refers to IVDMIAs as "some of the most promising developments in diagnostic testing to date." The new guidance will help clarify the agency's regulatory approach to these tests.

ASRs are commercially distributed active ingredients of medical tests. These chemicals are used in tests to diagnose diseases and conditions, and to guide medical decisionmaking. Companies commercially distributing ASRs must follow FDA requirements for marketing an in vitro diagnostic device. The draft guidance will clarify the definition and regulatory rules of these products, the agency said.