Although the report pokes a lot of holes in the existing process, it does not propose a detailed outline for a new one. "It is essential that the new regulatory framework be based on sound science," the report authors wrote. But the data needed to guide regulators toward a better process is in short supply. And that, according to the device industry, is a problem. "Replacing it at some unknown date with an untried, unproved and unspecific new legal structure would be a disservice to patients and the public health," Ubl noted.
For its part, the FDA has not committed to scrapping the established altogether. Those at the agency think that the "process should not be eliminated, but we are open to additional proposals and approaches for continued improvements of our device review programs," Jeffrey Shuren, director of the FDA's Center of Devices and Radiological Health, said in a prepared statement. In the meantime, "the public should continue to feel confident in the medical devices on the market today," he said.
One thing that seems implicit in the IOM's recommendations is that there should be a more thorough examination of medical devices before they are launched onto the market. But more stringent regulation is often seen as an impediment to innovation. And industry groups have been taking that angle in their fight against the report.
But Challoner and his colleagues suggest that the definition of "innovation" be expanded beyond the facile stats of sheer number of products on the market—or how long it took to get them there. True innovation should "instead focus on a broader understanding of the relationship among regulation, innovation, and patient health and safety throughout the device life cycle," they wrote. "There should be analysis of how incremental changes in existing devices affect clinical use, safety and effectiveness"—rather than a single-minded focus on getting new devices into doctors' hands before they are sure to be as safe—or safer—and effective than those devices already on the market.
There is still a long way to go before the FDA decides whether and to what extent to implement the recommendations, which would require authorization by Congress. The IOM report was just a starting point, Challoner says. "We pushed the snowball off the top of the hill," he adds, but estimates that it could be a few years until any legislation passes to significantly change the way medical devices find their way onto the market.