I have posted a number of notes about IVDMIAs (in-vitro diagnostic multivariate index assays), a term that was coined by the FDA to refer to panels of biomarkers plus a computer algorithm that is used to analyze the set of test results. The agency is now dropping the idea of issuing a final guidance on IVDMIAs and focusing more broadly on the agency's role in ensuring the safety and efficacy of all laboratory-developed tests (LDTs) (see: FDA Shelves IVDMIA Final Guidelines in Order to Focus on Overall LDT Regulation). Below is an excerpt from this article:
The FDA said in a Federal Register notice...that due to "public health concerns, … it is time to reconsider its policy of enforcement discretion over LDTs."....In a meeting scheduled for July 19-20 in Washington, DC, the agency will invite stakeholder input on its regulation of LDTs. After the July meeting and a subsequent comment period ending Aug. 15, the agency is planning to develop guidelines for public comment and "phase in" the regulatory framework outlined in the guidance over time. FDA's move to regulate all LDTs in a risk-based manner comes after industry stakeholders and advisory groups argued that the agency's selective regulatory approach to regulate only a subset of high-risk LDTs — IVDMIAs — led only to more confusion and created an uneven playing field. In December 2008, Genentech petitioned the FDA to take make its in vitro diagnostics regulations more consistent by extending its oversight over LDTs in a risk-based manner. The HHS Secretary's Advisory Committee on Genetics, Health, and Society issued a report in 2008, recommending much the same. The agency's public meeting on LDTs comes three years after the agency convened stakeholders to discuss its regulatory approach for IVDMIAs, lab-developed multiplex tests that employ mathematical algorithms to interpret a person's molecular-based risk for disease or likelihood of response to a drug.
That highly contentious meeting led to a second draft guidance on the topic that satisfied few players in industry. Along the way, FDA never finalized its IVDMIA guidance, but as the industry eagerly awaited more clarity on the topic from FDA, agency officials have issued conflicting timelines for when a final guidance may come out. Now, in light of the regulatory uproar surrounding the direct-to-consumer marketing of genetic tests [see: FDA Cracks Down on Consumer-Oriented Genetic Testing Web Sites], it seems FDA is dropping its work on an final IVDMIA guidance in order to clarify its broader regulatory authority over all LDTs, an authority the agency says it has, but hasn't exercised since the implementation of the Medical Device Amendments of 1976. The FDA has practiced enforcement discretion over the majority of LDTs, which are assays developed and analyzed at laboratories that have been accredited under...Clinical Laboratory Improvement Amendment [CLIA]. Although laboratories are certified to develop and analyze these tests, the assays themselves do not hold 510(k) clearance or a premarket approval from the FDA.
I don't have much to add to this -- the article is largely self-explanatory. In summary, after working on its IVDMIA policy for some three years, the FDA is integrating this discussion into the large issue of LDTs. You may better recognize by the slang term of home-brew tests. This controversy has simmered for years. I discovered an article on the web from 1992 on this same topic (see: Threat to 'home brew' products angers labs - Food and Drug Administration draft policy guide). This expanded discussion by the FDA will, no doubt, also encompass genomic/genetic testing. As noted above, all of this brouhaha boils down to the following question: what regulatory authority does the FDA hold over all LDTs.