By Jeffrey Gibbs, J.D.
FDA regulation of in vitro diagnostics (IVDs) continues to present industry with major uncertainties. Some of the major issues include:
- The In Vitro Diagnostic Multivariate Index Analysis guidance document represents FDA’s largest effort to regulate laboratory-developed tests. Although not released by the Bush Administration and criticized by many, the guidance document may be put into the public domain by the Obama Administration.
Questions surrounding the guidance document include: when might it be released? Has it been modified and if so, in what manner? How will it be implemented? And, what impact will it have on laboratories, kit manufacturers, investors, and patients? These uncertainties can impede product development, as well as raise investment risks during these troubled economic times.
- How will FDA expand its regulation of laboratory-developed tests (LDTs)? The Genentech citizen petition requested that FDA actively regulate a much broader segment of LDTs than covered by the IVDMIA proposal. Moreover, Congress may adopt, or at least consider, legislation that will lead to more FDA regulation of LDTs.
- The FDA has recognized the importance of the development of personalized medicine and companion diagnostics. Yet, FDA’s lack of clear policies has made it difficult for these IVDs to successfully complete the FDA review process.
The agency also has not adhered to the “least burdensome” mandate established by Congress for devices. Without clear, predictable, reasonable regulatory requirements, innovative IVDs will have a difficult time entering the market, and investment in them will lag. It remains to be seen what steps the new FDA administration will take to address these issues.
With some device reviewers complaining about FDA/Center for Devices and Radiological Health management to Congress, even greater regulatory stringency seems more likely.
As a result of these ongoing developments, companies whose interests are affected by FDA regulation of diagnostics will need to monitor events carefully. Diagnostic firms that are seeking to market new IVD assays in the U.S. will want to take steps to maximize the likelihood of a successful outcome perhaps by understanding their regulatory options, (GEN, July 2008), carefully crafting the intended use statement (GEN, November 15, 2008), and properly using the pre-IDE process to better understand the regulation requirements (GEN, March 1, 2009).