The FDA has issued two new draft guidances regarding "home brews" (i.e.,"in-house") and in vitro diagnostic tests.
The first guidance clarified a previous Analyte Specific Reagent (ASR) rule put forth by the FDA to establish guidelines for in-house test components. The draft guidance on ASRs also focused on the marketing strategies of ASR manufacturers.
Generally, the FDA recommended that an ASR should not be bundled with other ASRs, or other general reagents that portray that ASR as part of a test kit or system. The FDA further specified that an ASR cannot be marketed in a manner that gives the ASR a clear intentional use. The FDA asserts that ASRs marketed in such manner are subject to premarket review requirements.
The FDA's second draft guidance clarifies regulations set forth by the FDA on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs).
The FDA is working towards monitoring in-house tests by imposing regulations on the main components, which include, but are not limited to, ASRs (mentioned above), general purpose equipment, reagents or other laboratory instrumentation. The FDA does not consider that IVDMIAs fall under any of these currently regulated categories and clarifies, with this guidance, that any such in-house test that use IVDMIAs are subject to additional scrutiny by the FDA, such as pre- and post-market requirements.
These draft guidances reflect FDA's efforts to address the increasing number of "home brew" tests available to consumers.
Read the FDA Guidance Draft Report:
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Last Reviewed: February 11, 2014