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ODE to get complexity ratings duty
FDA will "soon" take over responsibility for determining the complexity level of laboratory tests from the Centers for Disease Control and Prevention (CDC), according to Kimber Richter, MD, deputy director of the Office of Device Evaluation (ODE) at FDA's Center for Devices and Radiological Health.
Speaking at the In Vitro Diagnostics Today conference, Richter said that the decision to have FDA take over complexity categorization is not yet final, but that planning for the change has already begun. The June conference was sponsored by the Regulatory Affairs Professionals Society (Rockville, MD). According to Richter, the likely scenario is that CDC staff will train FDA reviewers and that current determination criteria will not change.
ODE is also working to update its labeling policies for IVDs. Richter said that ODE expects to issue a guidance on discrepancy resolution and the use of gold standards within a month. The office is also considering whether to require manufacturers to report the relative sensitivity and specificity of their tests, and is examining the possibility of permitting different types of labeling for professional, prescription, or over-the-counter use. According to Richter, ODE is seeking industry input to suggest other areas of labeling that need attention.
Richter said that ODE is developing important policy initiatives in the areas of genetic testing, bioterrorism, and cancer screening. For the new field of genetic testing, Richter said that the agency is creating an advisory panel and developing policies. For cancer screening devices, Richter said that ODE needs to address how such devices should be defined and what the parameters for testing should be.
Speaking about ODE's goals, Richter observed that the office is committed to making voluntary standards work as part of the review process, and that review consistency and timeliness are high priorities. She acknowledged that accomplishing these goals will require ODE reviewers to stay on top of complex new IVD devices and rapidly evolving technologies.—Susan Wallace
