While there has been some discussion about the ways that medical devices are evaluated before they are permitted on the market, it’s clear that the pathway for these products runs through the Food and Drug Administration. The future pathway for diagnostics is not quite as clear. Though diagnostics have been regulated as laboratory developed tests falling under the oversight of the Centers for Medicare and Medicaid Services, the FDA has pushed to expand its regulatory scope to include diagnostics. Diagnostics developers expecting the FDA to assert this new role won’t be seeing it any time soon. The FDA has decided to delay finalizing its guidance on the matter. In fact, the regulator concedes it may never finalize such guidance, according to Genome Web.
In 2014, the FDA released draft guidelines outlining a regulatory framework for laboratory developed tests that would be phased in over the period of nine years. From the FDA’s point of view, new diagnostics employ complex algorithms and are marketed beyond laboratory settings – much like the products developed and marketed by the medical device industry. In contrast, laboratory developed tests historically have been confined to a single lab with limited marketing, Genome Web explains. The FDA proposed the draft guidance as a way of modernizing regulatory oversight of the newer, more complex diagnostics that are emerging. The agency has regarded the swath of largely unregulated new diagnostics as a “Wild West of medicine” that potentially puts patients at risk, according to the Wall Street Journal.
Diagnostics companies largely oppose FDA oversight of laboratory developed tests. Laboratories and pathologists see these tests as services, not devices, Genome Web explains. While these communities don’t oppose updating the regulations of laboratory developed tests, they believe that these updates should happen under the Clinical Laboratory Improvement Amendments, the program which currently sets standards for diagnostics.
There is another way that the FDA could expand its oversight to diagnostics without adopting its draft guidance. Genome Web notes that Alberto Gutierrez, the head of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said during a recent personalized medicine conference that the FDA could take an approach similar to that taken with next-generation sequencing-based tests. The FDA has established best practices for these tests, and has also issued draft guidance proposing a way it could regulate such tests.
Genome Web says Gutierrez’s comments marked the first time since issuing its planned guidance for laboratory tests that the agency has acknowledged it may never finalize these guidelines. Further muddying the FDA’s ambitions to expand its regulatory oversight is the change in political power following the November election. It’s unclear how much support a new secretary of the Department of Health and Human Services will have for the FDA’s position on laboratory tests, Genome Web says.
These FDA’s proposed laboratory guidelines have been years in the making. Any implementation, if it’s coming at all, may be years away. While recent developments do not give medical device and diagnostics companies perfect regulatory certainty, they do suggest that concerns that the CLIA framework they are accustomed to working under won’t be going away any time soon.
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