INDUSTRY NEWS
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Steven Gutman
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In 1997, FDA issued a rule that defined and classified ASRs, established labeling requirements, and imposed restrictions on ASR sale, distribution, and use. According to this rule, ASRs must follow the same marketing requirements as other IVD devices. In response to IVD manufacturers’ concerns, FDA’s new draft guidance provides further clarification by expanding upon ASR marketing practices, research, and investigational use.
“What is ironic about all of this is that there is an underlying disconnect in the IVD industry,” says Tom Tsakeris, president at Devices and Diagnostics Consulting Group Inc. (Rockville, MD). “There is historical unevenness between what is required of a traditional IVD company and what is required of laboratories.”
Leif Olsen, a regulatory affairs specialist at Hogan & Hartson LLP (Washington, DC), agrees. “FDA created this situation in a way, since it has been uneven in how it enforces the regulation,” he says. “But it is an imperfect world, and FDA cannot think of everything ahead of time.” He goes on to say that while he does not blame FDA, he feels this guidance is about two years overdue.
Confusion has existed regarding IVDMIA regulation when developed and used by laboratories. This is partially due to FDA’s regulation of laboratory-developed tests that use ASRs and other commercially available FDA-regulated components. The draft guidance addresses the definition and regulatory status of IVDMIAs, as well as premarket pathways and postmarket requirements for the tests, since FDA does not believe that IVDMIAs fall within the reach of laboratory-developed tests.
According to Glen Freiberg, president of RQC Consulting (San Diego), this is an important distinction: “If a laboratory manufactures all or part of an assay without using a manufacturer-supplied ASR, disclosure is not required.” He continues, “In these cases, physicians will have no idea that the assay does not have FDA clearance. OIVD’s new draft guidance will not affect this without a new regulation or clear enforcement directive.”
However, change can be costly for laboratories. “There is such a long history here of FDA oversight of laboratories,” Tsakeris says. “Laboratory services have spawned up without previous regulation. With the new guidance, companies will find themselves suddenly defined by FDA as having developed a new device.”
Steven Gutman, MD, director at the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), says that IVD companies should be motivated to demonstrate solid science regardless. “Companies need good core science to get FDA clearance, but they also need it to convince healthcare practitioners to order their tests as well as to ensure reimbursement,” he says.
Gutman also suggests that these documents should “not be overread.” He says the ASR guidance “simply clarifies the parameters for use of ASRs,” and the IVDMIA guidance applies to a “narrow niche of home-brew tests that FDA has decided not to apply enforcement discretion to, but to regulate as medical devices.” In addition, he emphasizes that this is not a fundamental change in policy with regard to home-brew assays. As far as ensuring equal enforcement, OIVD will rely on trade complaints within the industry. “Companies will turn each other in,” Gutman says.
However, industry analysts feel that this approach is an example of poor governance by FDA. “FDA has spent a lot of resources, time, and effort to develop these guidelines,” says Freiberg. “Publishing them and then basing enforcement on competition complaints does not serve the public health in an efficient manner.”
Likewise, other industry experts like Olson stress that further regulation can make costs escalate or prevent certain tests from hitting the market. “While it is a good idea, it is hard to predict the consequences in advance,” he emphasizes.
Additional information about these guidances can be accessed via OIVD’s Web site at www.fda.gov/cdrh/oivd/index.html.
